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CDC signs off on RSV vaccine for older adults
The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.
CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.
The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.
On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
RSV vaccines
RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.
The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.
The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.
He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.
Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.
The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.
Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.
A version of this article first appeared on WebMD.com.
This article was updated 7/5/23.
The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.
CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.
The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.
On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
RSV vaccines
RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.
The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.
The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.
He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.
Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.
The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.
Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.
A version of this article first appeared on WebMD.com.
This article was updated 7/5/23.
The Centers for Disease Control and Prevention has given a green light to two new vaccines to protect against respiratory syncytial virus, or RSV, in older adults.
CDC Director Rochelle P. Walensky, MD, MPH, agreed with and endorsed the recommendations made earlier by CDC advisors that people age 60 and over may get one of two new vaccines for RSV. Decisions should be made based on discussions with one’s health care provider about whether the vaccine is right for them, the federal health agency said.
The new vaccines, the first licensed in the United States to protect against the respiratory illness, are expected to be available this fall.
On June 21, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel, stopped short of recommending the vaccines for everyone age 65 and above, which was the original question the committee was to consider. The experts amended that question, changing it to whether the panel should recommend the vaccine for those 65 and above if the person and their doctor agreed. The committee voted 9 to 5 in favor.
RSV vaccines
RSV leads to 6,000 to 10,000 deaths a year in the United States among those age 65 and older and 60,000 to 160,000 hospitalizations in that group. Seniors and infants are among the most vulnerable to the lower respiratory infection, marked by runny nose, wheezing, sneezing, decreased appetite, and fever.
The FDA in May approved two vaccines — GSK’s Arexvy and Pfizer’s Abrysvo — for adults age 60 and above.
The vote recommending shared decision-making about the vaccine, instead of a routine vaccination recommended for all, “is a weaker recommendation,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University Medical Center in Nashville and medical director of the National Foundation for Infectious Diseases. Dr. Schaffner is a non-voting member of ACIP. He attended the meeting.
He said the experts voiced concern about a number of issues, including what some saw as a lack of sufficient data from trials on the most vulnerable groups, such as nursing home residents.
Experts also wanted more information about the duration of protection and exactly when a second dose might be needed. At the meeting, a GSK official said its vaccine was 84.6% effective after one and a half seasons, down from 94.1% after one season. A Pfizer official said its vaccine decreased the risk of RSV with three or more symptoms by 78.6% after a season and a half, down from 88.9% after one season.
The panel also wanted more data on whether the RSV vaccines could be administered at the same time as other vaccines recommended for adults.
Both companies gave a range of cost estimates. Pfizer expects its vaccine to cost $180 to $270 but said it could not guarantee that range. GSK said it expects a price of $200 to $295. Under the Inflation Reduction Act, recommended vaccines are covered under Medicare for those with Part D plans, which 51 million of 65 million Medicare patients have. Commercial insurance is likely to cover the vaccines if the CDC recommends them.
A version of this article first appeared on WebMD.com.
This article was updated 7/5/23.
Severe strep infections rebound after pandemic lull
Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections.
These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.
such as Colorado and Minnesota.
Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults.
Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.
A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.
Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.
People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.
A version of this article first appeared on Medscape.com.
Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections.
These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.
such as Colorado and Minnesota.
Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults.
Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.
A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.
Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.
People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.
A version of this article first appeared on Medscape.com.
Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections.
These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.
such as Colorado and Minnesota.
Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults.
Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.
A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.
Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.
People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.
A version of this article first appeared on Medscape.com.
FDA OKs empagliflozin for children with type 2 diabetes
aged 10 years and older.
This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.
Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).
Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.
“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.
“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
Type 2 diabetes rising exponentially in children, mainly non-Whites
Type 2 diabetes is rising exponentially in children and adolescents in the United States.
Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and it continues to rise.
A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.
Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.
At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.
Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.
Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.
“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.
A version of this article first appeared on Medscape.com.
aged 10 years and older.
This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.
Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).
Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.
“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.
“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
Type 2 diabetes rising exponentially in children, mainly non-Whites
Type 2 diabetes is rising exponentially in children and adolescents in the United States.
Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and it continues to rise.
A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.
Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.
At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.
Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.
Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.
“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.
A version of this article first appeared on Medscape.com.
aged 10 years and older.
This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.
Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).
Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.
“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.
“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
Type 2 diabetes rising exponentially in children, mainly non-Whites
Type 2 diabetes is rising exponentially in children and adolescents in the United States.
Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and it continues to rise.
A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.
Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.
At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.
Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.
Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.
“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.
A version of this article first appeared on Medscape.com.
FDA OKs low-dose colchicine for broad CV indication
The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.
The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications. 
The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.
Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.
Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.
In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI.
Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
‘A very big day for cardiology’
“This is a very big day for cardiology,” Dr. Ridker said in an interview.
“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.
Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.
He pointed out that
“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.
But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.
“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.
Dr. Ridker believes that physicians will need time to feel comfortable with this new approach.
“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.
Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.
The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.
Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.
More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.
The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.
The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications.
The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.
Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.
Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.
In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI.
Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
‘A very big day for cardiology’
“This is a very big day for cardiology,” Dr. Ridker said in an interview.
“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.
Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.
He pointed out that
“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.
But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.
“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.
Dr. Ridker believes that physicians will need time to feel comfortable with this new approach.
“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.
Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.
The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.
Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.
More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.
The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the anti-inflammatory drug colchicine 0.5 mg tablets (Lodoco) as the first specific anti-inflammatory drug demonstrated to reduce the risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.
The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications.
The drug’s manufacturer, Agepha Pharma, said it anticipates that Lodoco will be available for prescription in the second half of 2023.
Colchicine has been available for many years and used at higher doses for the acute treatment of gout and pericarditis, but the current formulation is a much lower dose for long-term use in patients with atherosclerotic heart disease.
Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT.
In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease. And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI.
Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, who has been a pioneer in establishing inflammation as an underlying cause of atherosclerotic cardiovascular disease, welcomed the Lodoco approval.
‘A very big day for cardiology’
“This is a very big day for cardiology,” Dr. Ridker said in an interview.
“The FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease,” he said.
Dr. Ridker was the lead author of a recent study showing that among patients receiving contemporary statins, inflammation assessed by high-sensitivity C-reactive protein (hsCRP) was a stronger predictor for risk of future cardiovascular events and death than LDL cholesterol.
He pointed out that
“That is virtually identical to the indication approved for statin therapy. That shows just how important the FDA thinks this is,” he commented.
But Dr. Ridker added that, while the label does not specify that Lodoco has to be used in addition to statin therapy, he believes that it will be used as additional therapy to statins in the vast majority of patients.
“This is not an alternative to statin therapy. In the randomized trials, the benefits were seen on top of statins,” he stressed.
Dr. Ridker believes that physicians will need time to feel comfortable with this new approach.
“Initially, I think, it will be used mainly by cardiologists who know about inflammation, but I believe over time it will be widely prescribed by internists, in much the same way as statins are used today,” he commented.
Dr. Ridker said he already uses low dose colchicine in his high-risk patients who have high levels of inflammation as seen on hsCRP testing. He believes this is where the drug will mostly be used initially, as this is where it is likely to be most effective.
The prescribing information states that Lodoco is contraindicated in patients who are taking strong CYP3A4 inhibitors or P-glycoprotein inhibitors, such as ketoconazole, fluconazole, and clarithromycin, and in patients with preexisting blood dyscrasias, renal failure, and severe hepatic impairment.
Common side effects reported in published clinical studies and literature with the use of colchicine are gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.
More serious adverse effects are listed as blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, and aplastic anemia; and neuromuscular toxicity in the form of myotoxicity including rhabdomyolysis, which may occur, especially in combination with other drugs known to cause this effect. If these adverse effects occur, it is recommended that the drug be stopped.
The prescribing information also notes that Lodoco may rarely and transiently impair fertility in males; and that patients with renal or hepatic impairment should be monitored closely for adverse effects of colchicine.
A version of this article first appeared on Medscape.com.
FDA panel backs new COVID booster focusing only on variants
but questioned whether the population as a whole needs booster shots and how often they should be given.
The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.
In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.
FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well.
The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
New shot every year?
The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include.
But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots.
Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection.
In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”
Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.
The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions.
“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.
Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later.
“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.
Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same.
The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.
But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2.
Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices.
Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu.
“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..
In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.
A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.
“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”
At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots.
He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.
“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.
“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.
Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.
“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said.
And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said.
“It looks like, probably by next fall, there’ll be further drift from this,” he said.
Informing the public
Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States.
CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.
“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.
Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation.
“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”
Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines.
“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.
A version of this article first appeared on WebMD.com.
but questioned whether the population as a whole needs booster shots and how often they should be given.
The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.
In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.
FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well.
The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
New shot every year?
The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include.
But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots.
Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection.
In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”
Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.
The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions.
“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.
Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later.
“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.
Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same.
The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.
But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2.
Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices.
Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu.
“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..
In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.
A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.
“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”
At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots.
He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.
“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.
“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.
Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.
“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said.
And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said.
“It looks like, probably by next fall, there’ll be further drift from this,” he said.
Informing the public
Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States.
CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.
“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.
Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation.
“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”
Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines.
“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.
A version of this article first appeared on WebMD.com.
but questioned whether the population as a whole needs booster shots and how often they should be given.
The Vaccines and Related Biological Products Advisory Committee of the FDA voted 21-0 in favor of the recommendation about the strain to be used in the next crop of vaccines.
In the briefing document for the meeting, FDA staff said the available evidence suggests that a monovalent (single-strain) XBB-lineage vaccine “is warranted” for the 2023-2024 vaccination campaign and would replace the current bivalent vaccine, which targets the original version of the virus and two strains from the Omicron variant.
FDA staff also noted how such a shift would be in line with the World Health Organization toward targeting the XBB family of subvariants. European regulators have done this as well.
The FDA is not obligated to act on the panel’s recommendations. But the agency often does and is highly likely to do so in this case. Vaccine companies will need the recommendation from the FDA to begin making vaccines for the fall.
New shot every year?
The FDA asked its expert panel to vote only on the question about the makeup of future vaccines in terms of which strain to include.
But panelists also raised other questions during the meeting, including concerns about moves toward tying COVID vaccinations into the model of annual flu shots.
Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, argued for greater focus on the response of T cells after vaccination, even in light of the already recognized waning of antibody protection.
In a recent Substack article, Dr. Offit called T cells the “unsung hero” of the pandemic. They take longer to develop after infection or vaccination than the antibodies that first attack the virus, but immune memory cells called B and T cells “are long-lived,” and their “protection against severe disease often lasts for years and sometimes decades.”
Dr. Offit said he was concerned about using a blanket approach for future recommendations for COVID vaccinations, following the one now in place for influenza vaccines.
The Centers for Disease Control and Prevention recommends flu shots for everyone 6 months and older, with rare exceptions.
“We need to continue to define who those high-risk groups are and not make this a recommendation for everybody every season,” he said.
Dr. Offit offered his own experience as an example. While he had been vaccinated against the virus’s early Wuhan strain, he still was infected, most likely with a variant that emerged later.
“That was a drifted virus. That’s why I had a mild infection but I didn’t have a severe infection, because presumably I had T cells which prevented that severe infection, which may last for years,” Dr. Offit said.
Pfizer and Moderna, the two companies that make mRNA-based COVID vaccines, are working on experimental products meant to protect against both flu and SARS-COv-2 in one shot. Novavax, maker of a more traditional protein-based COVID shot, is doing the same.
The idea of these combination products is to make it more convenient for people to protect against both viruses, while also offering companies some marketing advantages.
But without referring to these drugmakers’ plans for future combo flu-COVID shots, members of the FDA panel raised objections to an assumption of routine annual vaccines against variants of SARS-CoV-2.
Among the panelists who expressed concerns was Henry H. Bernstein, DO, a former member of the CDC’s Advisory Committee on Immunization Practices.
Bernstein questioned the approach of dubbing these the “2023-2024 formulas,” as this approach conveyed a sense of an expectation for a need for annual vaccines, as happens with flu.
“It’s not clear to me that this is a seasonal virus yet,” said Dr. Bernstein, who is also a professor of pediatrics at Hofstra University, Hempstead, N.Y..
In response to Dr. Bernstein’s point, Arnold Monto, MD, the acting chair of the FDA panel, suggested such a pattern could emerge, while also agreeing that it’s too soon to say for sure.
A professor emeritus at the University of Michigan, Ann Arbor, Dr. Monto’s career included pandemic planning and emergency response to virus outbreaks, including the 1968 Hong Kong influenza pandemic, avian influenza, and the original SARS.
“I think it’s premature to say that this virus will not become seasonal,” Dr. Monto said about SARS-CoV-2. “I agree. We’re not there yet, but we may be.”
At the end of the meeting, Dr. Monto recapped the meeting’s key points, noting that there was a general consensus that the XBB.1.5 subvariant would be the best to use in future COVID shots.
He also noted that Novavax, which makes the more traditional protein-based vaccine, along with Pfizer and Moderna, already have honed in on this subvariant, which would allow for rapid development of updated COVID vaccines.
“The fact that most of the manufacturers are ready to work on an XBB 1.5 [vaccine] is an added reason to select this strain or this variant, given the immunologic data,” Dr. Monto said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said the demands involved in manufacturing vaccines tilts toward annual changes.
“Practically, we’re going to have one update per year, barring a heroic effort to deal with a strain that pops up that is essentially so different that it requires us to mobilize tremendous resources to address that strain change,” he said.
Dr. Marks questioned the panelists’ concerns about likening flu and COVID vaccination practices. The FDA staff’s intent was to try to help the public understand the need for follow-on vaccination.
“I’m really having trouble understanding that committee’s need to bristle against something that’s similar to influenza. People understand a yearly influenza vaccine,” Dr. Marks said.
And it’s not certain when another major change in the COVID virus will follow the XBB subvariant, but it’s likely one will – and soon, Dr. Marks said.
“It looks like, probably by next fall, there’ll be further drift from this,” he said.
Informing the public
Dr. Marks also stressed the need to better convey the benefits of vaccination to people in the United States.
CDC data estimate that 70% of the U.S. population completed an initial series of the original monovalent vaccines, with only 17% then getting bivalent shots. There’s even a decline among people ages 65 and older. CDC estimates 94% of this group completed their primary series, but only 43% got the bivalent booster dose.
“We have to do better because we have not done a good job today communicating to the American public what’s going on here,” Marks said.
Researchers also are still trying to determine the best timing for people to get additional COVID shots. Finding the “sweet spot” where people can maximize additional protection is tricky, with people most protected if they happen to get shot near the beginning of an uptick in viral spread, the CDC’s Ruth Link-Gelles, PhD, MPH, told the panel during a presentation.
“You’re going to get the best incremental benefit if it’s been longer since your last vaccine,” she said. “But of course, if you wait too long since your last vaccine, you’re left with very little protection, and so you’re at higher risk of severe illness.”
Like Dr. Marks, Dr. Link-Gelles stressed the need for persuading more people to get follow-on vaccines.
“Most Americans, at this point, haven’t even received the bivalent and so are a year or more out from their monovalent dose and so have relatively little protection left,” she said.
A version of this article first appeared on WebMD.com.
FDA approves first-ever OTC erectile dysfunction gel
The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.
The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.
According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex.
A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.
Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.
Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.
A version of this article originally appeared on WebMD.com.
The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.
The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.
According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex.
A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.
Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.
Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.
A version of this article originally appeared on WebMD.com.
The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe.
The Food and Drug Administration has approved the drug, called Eroxon, noting that it is a first-of-its-kind treatment. Eroxon is made by the British pharmaceutical company Futura Medical, which specializes in drugs that are given through the skin.
According to the product’s leaflet, Eroxon “stimulates blood flow in the penis through a unique physical cooling then warming effect, helping you get and keep an erection hard enough for sex.” The company said on the product’s website that 65% of people who used the drug were able to have sex.
A company spokesperson told CNN that the price of the product has not been set in the United States, but it costs the equivalent of about $31 in the United Kingdom. Futura Medical has not announced when it will be available in the United States.
Harvard Health reports that 30 million people in the United States have erectile dysfunction, which means a person cannot get an erection at all or one firm enough to have sex. The disorder is often linked to other physical or mental health problems, such as heart problems or clogged arteries.
Erectile dysfunction affects 1% of men in their 40s, 17% of men in their 60s, and nearly 50% of men who are age 75 or older, according to Harvard Health.
A version of this article originally appeared on WebMD.com.
Sewer data says Ohio person has had COVID for 2 years
The strain of the virus appears to be unique, the researchers said.
The mutated version of the virus was discovered by a team of researchers, led by University of Missouri–Columbia virologist Marc Johnson, PhD, that has been studying standalone mutations identified in wastewater. On Twitter, Dr. Johnson said their work could help warn people of a potential risk.
“If you knew of an exposure of a group of people to a deadly disease, there would be an obligation to inform them,” he wrote.
He believes the infected person lives in Columbus, works at a courthouse in a nearby county, and has gut health problems. The county where the person works has a population of just 15,000 people but had record COVID wastewater levels in May, The Columbus Dispatch reported. The unique COVID strain that Dr. Johnson is researching was the only COVID strain found in Fayette County’s wastewater.
“This person was shedding thousands of times more material than a normal person ever would,” Dr. Johnson told the Dispatch. “I think this person isn’t well. ... I’m guessing they have GI issues.”
Monitoring wastewater for COVID-19 is only used to inform public health officials of community levels and spread of the virus. People with COVID are not tracked down using such information.
The Centers for Disease Control and Prevention told the Dispatch that the findings do not mean there’s a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC wrote in a statement to the newspaper. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
Ohio health officials told the newspaper that they don’t consider the situation a public health threat because the cryptic strain hasn’t spread beyond two sewer sheds for those 2 years.
Dr. Johnson and colleagues have been researching other unique COVID strains found in wastewater. They wrote a paper about a case in Wisconsin currently in preprint.
In the paper, the researchers suggest some people are persistently infected, calling them “prolonged shedders.” The researchers wrote that prolonged shedders could be human or “nonhuman,” and that “increased global monitoring of such lineages in wastewater could help anticipate future circulating mutations and/or variants of concern.”
Earlier in 2023, the CDC announced it was ending its community-level reporting of COVID test data and would rely more heavily on hospitalization reports and wastewater monitoring. COVID hospitalizations dipped to 7,212 nationally for the week of June 1-8, which is a 6% decline from the week prior, according to the CDC. That number of hospitalizations equals about two hospitalizations per 100,000 people.
A version of this article first appeared on WebMD.com.
The strain of the virus appears to be unique, the researchers said.
The mutated version of the virus was discovered by a team of researchers, led by University of Missouri–Columbia virologist Marc Johnson, PhD, that has been studying standalone mutations identified in wastewater. On Twitter, Dr. Johnson said their work could help warn people of a potential risk.
“If you knew of an exposure of a group of people to a deadly disease, there would be an obligation to inform them,” he wrote.
He believes the infected person lives in Columbus, works at a courthouse in a nearby county, and has gut health problems. The county where the person works has a population of just 15,000 people but had record COVID wastewater levels in May, The Columbus Dispatch reported. The unique COVID strain that Dr. Johnson is researching was the only COVID strain found in Fayette County’s wastewater.
“This person was shedding thousands of times more material than a normal person ever would,” Dr. Johnson told the Dispatch. “I think this person isn’t well. ... I’m guessing they have GI issues.”
Monitoring wastewater for COVID-19 is only used to inform public health officials of community levels and spread of the virus. People with COVID are not tracked down using such information.
The Centers for Disease Control and Prevention told the Dispatch that the findings do not mean there’s a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC wrote in a statement to the newspaper. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
Ohio health officials told the newspaper that they don’t consider the situation a public health threat because the cryptic strain hasn’t spread beyond two sewer sheds for those 2 years.
Dr. Johnson and colleagues have been researching other unique COVID strains found in wastewater. They wrote a paper about a case in Wisconsin currently in preprint.
In the paper, the researchers suggest some people are persistently infected, calling them “prolonged shedders.” The researchers wrote that prolonged shedders could be human or “nonhuman,” and that “increased global monitoring of such lineages in wastewater could help anticipate future circulating mutations and/or variants of concern.”
Earlier in 2023, the CDC announced it was ending its community-level reporting of COVID test data and would rely more heavily on hospitalization reports and wastewater monitoring. COVID hospitalizations dipped to 7,212 nationally for the week of June 1-8, which is a 6% decline from the week prior, according to the CDC. That number of hospitalizations equals about two hospitalizations per 100,000 people.
A version of this article first appeared on WebMD.com.
The strain of the virus appears to be unique, the researchers said.
The mutated version of the virus was discovered by a team of researchers, led by University of Missouri–Columbia virologist Marc Johnson, PhD, that has been studying standalone mutations identified in wastewater. On Twitter, Dr. Johnson said their work could help warn people of a potential risk.
“If you knew of an exposure of a group of people to a deadly disease, there would be an obligation to inform them,” he wrote.
He believes the infected person lives in Columbus, works at a courthouse in a nearby county, and has gut health problems. The county where the person works has a population of just 15,000 people but had record COVID wastewater levels in May, The Columbus Dispatch reported. The unique COVID strain that Dr. Johnson is researching was the only COVID strain found in Fayette County’s wastewater.
“This person was shedding thousands of times more material than a normal person ever would,” Dr. Johnson told the Dispatch. “I think this person isn’t well. ... I’m guessing they have GI issues.”
Monitoring wastewater for COVID-19 is only used to inform public health officials of community levels and spread of the virus. People with COVID are not tracked down using such information.
The Centers for Disease Control and Prevention told the Dispatch that the findings do not mean there’s a public health threat.
“Unusual or ‘cryptic’ sequences identified in wastewater may represent viruses that can replicate in particular individuals, but not in the general population,” the CDC wrote in a statement to the newspaper. “This can be because of a compromised immune system. CDC and other institutions conduct studies in immunocompromised individuals to understand persistent infection and virus evolution.”
Ohio health officials told the newspaper that they don’t consider the situation a public health threat because the cryptic strain hasn’t spread beyond two sewer sheds for those 2 years.
Dr. Johnson and colleagues have been researching other unique COVID strains found in wastewater. They wrote a paper about a case in Wisconsin currently in preprint.
In the paper, the researchers suggest some people are persistently infected, calling them “prolonged shedders.” The researchers wrote that prolonged shedders could be human or “nonhuman,” and that “increased global monitoring of such lineages in wastewater could help anticipate future circulating mutations and/or variants of concern.”
Earlier in 2023, the CDC announced it was ending its community-level reporting of COVID test data and would rely more heavily on hospitalization reports and wastewater monitoring. COVID hospitalizations dipped to 7,212 nationally for the week of June 1-8, which is a 6% decline from the week prior, according to the CDC. That number of hospitalizations equals about two hospitalizations per 100,000 people.
A version of this article first appeared on WebMD.com.
FDA approves first treatment for constipation in children
The recommended dosage in pediatric patients is 72 mcg orally once daily.
Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA noted in a statement announcing the approval.
The efficacy of linaclotide in children with functional constipation was demonstrated in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial (Trial 7; NCT04026113) and supported by efficacy data from trials in adults with chronic idiopathic constipation, the FDA said.
The FDA first approved linaclotide in 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
Study details
To be eligible for the pediatric clinical trial, patients had to have experienced fewer than three spontaneous bowel movements (SBMs) per week.
They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:
- History of stool withholding or excessive voluntary stool retention.
- History of painful or hard bowel movements.
- History of large diameter stools that may obstruct the toilet.
- Presence of a large fecal mass in the rectum.
- At least one episode of fecal incontinence per week.
The primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.
SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period, the FDA said.
The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
The product’s boxed warning states that linaclotide is contraindicated in children younger than 2 years. In neonatal mice, linaclotide caused deaths due to dehydration.
Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
The application for linaclotide in children received priority review.
A version of this article originally appeared on Medscape.com.
The recommended dosage in pediatric patients is 72 mcg orally once daily.
Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA noted in a statement announcing the approval.
The efficacy of linaclotide in children with functional constipation was demonstrated in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial (Trial 7; NCT04026113) and supported by efficacy data from trials in adults with chronic idiopathic constipation, the FDA said.
The FDA first approved linaclotide in 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
Study details
To be eligible for the pediatric clinical trial, patients had to have experienced fewer than three spontaneous bowel movements (SBMs) per week.
They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:
- History of stool withholding or excessive voluntary stool retention.
- History of painful or hard bowel movements.
- History of large diameter stools that may obstruct the toilet.
- Presence of a large fecal mass in the rectum.
- At least one episode of fecal incontinence per week.
The primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.
SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period, the FDA said.
The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
The product’s boxed warning states that linaclotide is contraindicated in children younger than 2 years. In neonatal mice, linaclotide caused deaths due to dehydration.
Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
The application for linaclotide in children received priority review.
A version of this article originally appeared on Medscape.com.
The recommended dosage in pediatric patients is 72 mcg orally once daily.
Functional constipation is common in children and adolescents. Symptoms include infrequent bowel movements with hard stools that can be difficult or painful to pass.
There is no known underlying organic cause and there are typically multiple contributing factors, the FDA noted in a statement announcing the approval.
The efficacy of linaclotide in children with functional constipation was demonstrated in a 12-week double-blind, placebo-controlled, randomized, multicenter clinical trial (Trial 7; NCT04026113) and supported by efficacy data from trials in adults with chronic idiopathic constipation, the FDA said.
The FDA first approved linaclotide in 2012 for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.
Study details
To be eligible for the pediatric clinical trial, patients had to have experienced fewer than three spontaneous bowel movements (SBMs) per week.
They also had to experience one or more of the following at least once weekly, for at least 2 months prior to the trial screening visit:
- History of stool withholding or excessive voluntary stool retention.
- History of painful or hard bowel movements.
- History of large diameter stools that may obstruct the toilet.
- Presence of a large fecal mass in the rectum.
- At least one episode of fecal incontinence per week.
The primary efficacy endpoint was a 12-week change from baseline in SBM frequency rate. Children on linaclotide experienced greater improvement in the average number of SBMs per week than peers given placebo.
SBM frequency improved during the first week and was maintained throughout the remainder of the 12-week treatment period, the FDA said.
The most common adverse reaction is diarrhea. If severe diarrhea occurs, linaclotide should be discontinued and rehydration started.
The product’s boxed warning states that linaclotide is contraindicated in children younger than 2 years. In neonatal mice, linaclotide caused deaths due to dehydration.
Patients with known or suspected mechanical gastrointestinal obstruction should not take linaclotide.
Full prescribing information is available online.
The application for linaclotide in children received priority review.
A version of this article originally appeared on Medscape.com.
FDA panel unanimously endorses lecanemab for Alzheimer’s
“Overall, the study demonstrated clearly that this is an effective treatment,” said acting chair Robert C. Alexander, MD, chief scientific officer, Alzheimer’s Prevention Initiative, Banner Alzheimer’s Institute, and research professor, department of psychiatry, University of Arizona, Phoenix, during the meeting.
An intravenous infusion targeting amyloid-beta, lecanemab received accelerated FDA approved earlier in 2023 for the treatment of early Alzheimer’s disease (AD). The company was required to complete a confirmatory study to verify and describe the product’s clinical benefit.
The Peripheral and Central Nervous System Drugs Advisory Committee met to discuss this phase 3 study (CLARITY-AD). The multicenter, double-blind study included 1,795 patients (mean age, 71 years) who had mild cognitive impairment caused by AD or mild AD dementia.
Delayed progression
Study participants had a broad range of comorbidities, and many were concomitantly receiving other medications. Black people were underrepresented in the study at just 3% of the total cohort.
Patients were randomly assigned to receive placebo or lecanemab 10 mg/kg biweekly. In addition to a placebo-controlled period and safety follow-up, the study has an ongoing extension phase of up to 4 years.
The study met its primary endpoint, showing a highly statistically significant 27% less decline on the Clinical Dementia Rating-Sum of Boxes at 18 months (difference in adjusted mean, –0.45; 95% CI, –0.67 to –0.23; P = .00005).
This was supported by a significant 26% difference on the AD Assessment Scale–Cognitive Subscale with 14 tasks (ADAS-Cog 14).
The drug also affected function, with a 37% decrease, compared with placebo, on the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment.
Committee members heard that the results signal delays in disease progression by about 5 months, giving patients more time to live independently and participate in hobbies and interests.
Patients who received the active drug also experienced quality of life benefits. Compared with patients who received placebo, those who took lecanemab had 49% less decline as measured with the European Quality of Life–5 Dimensions scale and 56% less decline as measured by the Quality of Life in AD scale, and caregivers reported less burden.
Lecanemab also affected biomarkers of amyloid, tau, and neurodegeneration, providing a biological basis for the treatment effects consistent with slowing of disease progression.
Unanimous support
All six committee members agreed by vote that the study provides evidence of clinical benefit. They variously descried the study and results as “robust,” “compelling,” “well conducted,” “clear and consistent,” and “clinically meaningful.”
In the active treatment group, there was a higher incidence of amyloid-related imaging abnormalities (ARIAs), which can be serious and life-threatening but are usually asymptomatic. In this study, most ARIAs had resolved by 3 months.
Deaths occurred in 0.8% of the placebo and 0.7% of the treatment group. Dean Follmann, PhD, assistant director for biostatistics, National Institute of Allergy and Infectious Diseases, Bethesda, Md., noted that the numbers of deaths and serious adverse events were “quite similar” in the two groups.
“And for serious ARIA, there was an imbalance favoring placebo, but overall, these were pretty rare,” he said.
Subgroup concerns
Committee members discussed the risk/benefit profile for three subgroups of patients – those with apolipoprotein E4 (apo E4) allele, patients taking an anticoagulant, and those with cerebral amyloid angiopathy (CAA).
In the apo E4 group, the study’s primary endpoint did not favor the drug, but secondary endpoints did.
“I think the general feeling [for apo E4 status] is that the risk/benefit still remains favorable, especially when looking across multiple endpoints,” said Dr. Alexander.
However, some members supported recommending genetic testing before initiating the drug.
The views were more diverse for the use of lecanemab in the presence of an anticoagulant, which may increase the risk for cerebral hemorrhage. Some committee members strongly recommended that these patients not receive lecanemab, while others highlighted the need for more information, owing to uncertainties about the risks.
With respect to CAA, most members supported the idea of considering use of the drug in the presence of this condition, but only after discussing the risks with patients and their families and in the presence of a robust reporting system.
An Alzheimer’s Association representative was in attendance during the public hearing portion of the meeting to express support for traditional approval of lecanemab for people with early AD.
The association strongly favors full Medicare coverage for FDA-approved AD treatments. The Centers for Medicare & Medicaid Services has determined that AD treatments receiving traditional FDA approval will be covered if clinicians register and enter data in a registry.
“While this is an important signal that CMS wants to improve access to FDA-approved treatments, registry as a condition of coverage is an unnecessary and potentially harmful barrier,” said the Alzheimer’s Association in a press release following the meeting.
A version of this article first appeared on Medscape.com.
“Overall, the study demonstrated clearly that this is an effective treatment,” said acting chair Robert C. Alexander, MD, chief scientific officer, Alzheimer’s Prevention Initiative, Banner Alzheimer’s Institute, and research professor, department of psychiatry, University of Arizona, Phoenix, during the meeting.
An intravenous infusion targeting amyloid-beta, lecanemab received accelerated FDA approved earlier in 2023 for the treatment of early Alzheimer’s disease (AD). The company was required to complete a confirmatory study to verify and describe the product’s clinical benefit.
The Peripheral and Central Nervous System Drugs Advisory Committee met to discuss this phase 3 study (CLARITY-AD). The multicenter, double-blind study included 1,795 patients (mean age, 71 years) who had mild cognitive impairment caused by AD or mild AD dementia.
Delayed progression
Study participants had a broad range of comorbidities, and many were concomitantly receiving other medications. Black people were underrepresented in the study at just 3% of the total cohort.
Patients were randomly assigned to receive placebo or lecanemab 10 mg/kg biweekly. In addition to a placebo-controlled period and safety follow-up, the study has an ongoing extension phase of up to 4 years.
The study met its primary endpoint, showing a highly statistically significant 27% less decline on the Clinical Dementia Rating-Sum of Boxes at 18 months (difference in adjusted mean, –0.45; 95% CI, –0.67 to –0.23; P = .00005).
This was supported by a significant 26% difference on the AD Assessment Scale–Cognitive Subscale with 14 tasks (ADAS-Cog 14).
The drug also affected function, with a 37% decrease, compared with placebo, on the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment.
Committee members heard that the results signal delays in disease progression by about 5 months, giving patients more time to live independently and participate in hobbies and interests.
Patients who received the active drug also experienced quality of life benefits. Compared with patients who received placebo, those who took lecanemab had 49% less decline as measured with the European Quality of Life–5 Dimensions scale and 56% less decline as measured by the Quality of Life in AD scale, and caregivers reported less burden.
Lecanemab also affected biomarkers of amyloid, tau, and neurodegeneration, providing a biological basis for the treatment effects consistent with slowing of disease progression.
Unanimous support
All six committee members agreed by vote that the study provides evidence of clinical benefit. They variously descried the study and results as “robust,” “compelling,” “well conducted,” “clear and consistent,” and “clinically meaningful.”
In the active treatment group, there was a higher incidence of amyloid-related imaging abnormalities (ARIAs), which can be serious and life-threatening but are usually asymptomatic. In this study, most ARIAs had resolved by 3 months.
Deaths occurred in 0.8% of the placebo and 0.7% of the treatment group. Dean Follmann, PhD, assistant director for biostatistics, National Institute of Allergy and Infectious Diseases, Bethesda, Md., noted that the numbers of deaths and serious adverse events were “quite similar” in the two groups.
“And for serious ARIA, there was an imbalance favoring placebo, but overall, these were pretty rare,” he said.
Subgroup concerns
Committee members discussed the risk/benefit profile for three subgroups of patients – those with apolipoprotein E4 (apo E4) allele, patients taking an anticoagulant, and those with cerebral amyloid angiopathy (CAA).
In the apo E4 group, the study’s primary endpoint did not favor the drug, but secondary endpoints did.
“I think the general feeling [for apo E4 status] is that the risk/benefit still remains favorable, especially when looking across multiple endpoints,” said Dr. Alexander.
However, some members supported recommending genetic testing before initiating the drug.
The views were more diverse for the use of lecanemab in the presence of an anticoagulant, which may increase the risk for cerebral hemorrhage. Some committee members strongly recommended that these patients not receive lecanemab, while others highlighted the need for more information, owing to uncertainties about the risks.
With respect to CAA, most members supported the idea of considering use of the drug in the presence of this condition, but only after discussing the risks with patients and their families and in the presence of a robust reporting system.
An Alzheimer’s Association representative was in attendance during the public hearing portion of the meeting to express support for traditional approval of lecanemab for people with early AD.
The association strongly favors full Medicare coverage for FDA-approved AD treatments. The Centers for Medicare & Medicaid Services has determined that AD treatments receiving traditional FDA approval will be covered if clinicians register and enter data in a registry.
“While this is an important signal that CMS wants to improve access to FDA-approved treatments, registry as a condition of coverage is an unnecessary and potentially harmful barrier,” said the Alzheimer’s Association in a press release following the meeting.
A version of this article first appeared on Medscape.com.
“Overall, the study demonstrated clearly that this is an effective treatment,” said acting chair Robert C. Alexander, MD, chief scientific officer, Alzheimer’s Prevention Initiative, Banner Alzheimer’s Institute, and research professor, department of psychiatry, University of Arizona, Phoenix, during the meeting.
An intravenous infusion targeting amyloid-beta, lecanemab received accelerated FDA approved earlier in 2023 for the treatment of early Alzheimer’s disease (AD). The company was required to complete a confirmatory study to verify and describe the product’s clinical benefit.
The Peripheral and Central Nervous System Drugs Advisory Committee met to discuss this phase 3 study (CLARITY-AD). The multicenter, double-blind study included 1,795 patients (mean age, 71 years) who had mild cognitive impairment caused by AD or mild AD dementia.
Delayed progression
Study participants had a broad range of comorbidities, and many were concomitantly receiving other medications. Black people were underrepresented in the study at just 3% of the total cohort.
Patients were randomly assigned to receive placebo or lecanemab 10 mg/kg biweekly. In addition to a placebo-controlled period and safety follow-up, the study has an ongoing extension phase of up to 4 years.
The study met its primary endpoint, showing a highly statistically significant 27% less decline on the Clinical Dementia Rating-Sum of Boxes at 18 months (difference in adjusted mean, –0.45; 95% CI, –0.67 to –0.23; P = .00005).
This was supported by a significant 26% difference on the AD Assessment Scale–Cognitive Subscale with 14 tasks (ADAS-Cog 14).
The drug also affected function, with a 37% decrease, compared with placebo, on the AD Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment.
Committee members heard that the results signal delays in disease progression by about 5 months, giving patients more time to live independently and participate in hobbies and interests.
Patients who received the active drug also experienced quality of life benefits. Compared with patients who received placebo, those who took lecanemab had 49% less decline as measured with the European Quality of Life–5 Dimensions scale and 56% less decline as measured by the Quality of Life in AD scale, and caregivers reported less burden.
Lecanemab also affected biomarkers of amyloid, tau, and neurodegeneration, providing a biological basis for the treatment effects consistent with slowing of disease progression.
Unanimous support
All six committee members agreed by vote that the study provides evidence of clinical benefit. They variously descried the study and results as “robust,” “compelling,” “well conducted,” “clear and consistent,” and “clinically meaningful.”
In the active treatment group, there was a higher incidence of amyloid-related imaging abnormalities (ARIAs), which can be serious and life-threatening but are usually asymptomatic. In this study, most ARIAs had resolved by 3 months.
Deaths occurred in 0.8% of the placebo and 0.7% of the treatment group. Dean Follmann, PhD, assistant director for biostatistics, National Institute of Allergy and Infectious Diseases, Bethesda, Md., noted that the numbers of deaths and serious adverse events were “quite similar” in the two groups.
“And for serious ARIA, there was an imbalance favoring placebo, but overall, these were pretty rare,” he said.
Subgroup concerns
Committee members discussed the risk/benefit profile for three subgroups of patients – those with apolipoprotein E4 (apo E4) allele, patients taking an anticoagulant, and those with cerebral amyloid angiopathy (CAA).
In the apo E4 group, the study’s primary endpoint did not favor the drug, but secondary endpoints did.
“I think the general feeling [for apo E4 status] is that the risk/benefit still remains favorable, especially when looking across multiple endpoints,” said Dr. Alexander.
However, some members supported recommending genetic testing before initiating the drug.
The views were more diverse for the use of lecanemab in the presence of an anticoagulant, which may increase the risk for cerebral hemorrhage. Some committee members strongly recommended that these patients not receive lecanemab, while others highlighted the need for more information, owing to uncertainties about the risks.
With respect to CAA, most members supported the idea of considering use of the drug in the presence of this condition, but only after discussing the risks with patients and their families and in the presence of a robust reporting system.
An Alzheimer’s Association representative was in attendance during the public hearing portion of the meeting to express support for traditional approval of lecanemab for people with early AD.
The association strongly favors full Medicare coverage for FDA-approved AD treatments. The Centers for Medicare & Medicaid Services has determined that AD treatments receiving traditional FDA approval will be covered if clinicians register and enter data in a registry.
“While this is an important signal that CMS wants to improve access to FDA-approved treatments, registry as a condition of coverage is an unnecessary and potentially harmful barrier,” said the Alzheimer’s Association in a press release following the meeting.
A version of this article first appeared on Medscape.com.
FDA class 1 recall for some Abiomed Impella heart pumps
“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the U.S. Food and Drug Administration says in an advisory posted on its website.
“If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death,” the FDA says.
The FDA has identified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, Abiomed says it has received 179 complaints; there have been three injuries and no deaths related to this problem.
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the ventricles in the setting of ongoing cardiogenic shock that occurs less than 48 hours after acute myocardial infarction, open-heart surgery, or when the heart is not functioning well owing to cardiomyopathy.
All the devices that are being recalled were distributed from September 2021 to March 2023. Detailed product information is available on the FDA website.
Abiomed has sent an urgent medical device recall letter to customers asking them to review their inventory to check for any recalled product and to contact Abiomed customer support to coordinate return of the product.
Customers are advised not to use affected products unless no other product is available. The letter includes “best practices” for situations in which no other option is available and the device must be used until a replacement is available.
Customers with questions about this recall should contact Abiomed’s clinical support center at 1-800-422-8666.
A version of this article was first published on Medscape.com.
“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the U.S. Food and Drug Administration says in an advisory posted on its website.
“If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death,” the FDA says.
The FDA has identified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, Abiomed says it has received 179 complaints; there have been three injuries and no deaths related to this problem.
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the ventricles in the setting of ongoing cardiogenic shock that occurs less than 48 hours after acute myocardial infarction, open-heart surgery, or when the heart is not functioning well owing to cardiomyopathy.
All the devices that are being recalled were distributed from September 2021 to March 2023. Detailed product information is available on the FDA website.
Abiomed has sent an urgent medical device recall letter to customers asking them to review their inventory to check for any recalled product and to contact Abiomed customer support to coordinate return of the product.
Customers are advised not to use affected products unless no other product is available. The letter includes “best practices” for situations in which no other option is available and the device must be used until a replacement is available.
Customers with questions about this recall should contact Abiomed’s clinical support center at 1-800-422-8666.
A version of this article was first published on Medscape.com.
“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the U.S. Food and Drug Administration says in an advisory posted on its website.
“If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death,” the FDA says.
The FDA has identified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, Abiomed says it has received 179 complaints; there have been three injuries and no deaths related to this problem.
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the ventricles in the setting of ongoing cardiogenic shock that occurs less than 48 hours after acute myocardial infarction, open-heart surgery, or when the heart is not functioning well owing to cardiomyopathy.
All the devices that are being recalled were distributed from September 2021 to March 2023. Detailed product information is available on the FDA website.
Abiomed has sent an urgent medical device recall letter to customers asking them to review their inventory to check for any recalled product and to contact Abiomed customer support to coordinate return of the product.
Customers are advised not to use affected products unless no other product is available. The letter includes “best practices” for situations in which no other option is available and the device must be used until a replacement is available.
Customers with questions about this recall should contact Abiomed’s clinical support center at 1-800-422-8666.
A version of this article was first published on Medscape.com.