Becky Jungbauer

RHEUMATOLOGY NEWS and “The Pink Sheet” are published by Elsevier.

A Food and Drug Administration panel has recommended that the agency approve etanercept for moderate to severe plaque psoriasis in pediatric patients; however, some members expressed concern over labeling for moderate psoriasis, preferring that the FDA approve the product for severe cases only.

The Dermatologic and Ophthalmic Drugs Advisory Committee voted 8-5, saying that the drug manufacturer (Amgen Inc.) provided sufficient information to demonstrate the safety and efficacy of etanercept (Enbrel) in the pediatric population with severe psoriasis. But members noted a lack of data on long-term adverse events and maintenance of the treatment effect. The outside medical experts also were divided over whether the tumor necrosis factor blocker's risks outweighed its benefits for patients with moderate psoriasis.

The FDA presented data showing the product's adverse events, including life-threatening infections and malignancies. Amgen's senior vice president for global regulatory affairs and safety, Paul Eisenberg, acknowledged that the benefit and risk have not been established beyond 1 year in the pediatric population.

Nevertheless, the panel moved to give physicians the option of prescribing the product. Consumer representative Mary Majumder said, “Nobody wants this to be used widely, and nobody wants it never to be used.”

Enbrel already is used off label for the proposed indication, and Amgen intends to continue gathering clinical data on the indication, which helped sway committee members to vote in its favor.

The company said it will target several thousand pediatric patients, aged 4-17 years, over the next few years in proposed postmarketing studies, including a prospective long-term safety registry with a minimum 5-year follow-up. It also plans to extend its current 3-year open-label extension study to 5 years.

The same committee unanimously voted in favor of approving Centocor Inc.'s ustekinumab recently, also calling for additional long-term studies.

RHEUMATOLOGY NEWS and “The Pink Sheet” are published by Elsevier.

A Food and Drug Administration panel has recommended that the agency approve etanercept for moderate to severe plaque psoriasis in pediatric patients; however, some members expressed concern over labeling for moderate psoriasis, preferring that the FDA approve the product for severe cases only.

The Dermatologic and Ophthalmic Drugs Advisory Committee voted 8-5, saying that the drug manufacturer (Amgen Inc.) provided sufficient information to demonstrate the safety and efficacy of etanercept (Enbrel) in the pediatric population with severe psoriasis. But members noted a lack of data on long-term adverse events and maintenance of the treatment effect. The outside medical experts also were divided over whether the tumor necrosis factor blocker's risks outweighed its benefits for patients with moderate psoriasis.

The FDA presented data showing the product's adverse events, including life-threatening infections and malignancies. Amgen's senior vice president for global regulatory affairs and safety, Paul Eisenberg, acknowledged that the benefit and risk have not been established beyond 1 year in the pediatric population.

Nevertheless, the panel moved to give physicians the option of prescribing the product. Consumer representative Mary Majumder said, “Nobody wants this to be used widely, and nobody wants it never to be used.”

Enbrel already is used off label for the proposed indication, and Amgen intends to continue gathering clinical data on the indication, which helped sway committee members to vote in its favor.

The company said it will target several thousand pediatric patients, aged 4-17 years, over the next few years in proposed postmarketing studies, including a prospective long-term safety registry with a minimum 5-year follow-up. It also plans to extend its current 3-year open-label extension study to 5 years.

The same committee unanimously voted in favor of approving Centocor Inc.'s ustekinumab recently, also calling for additional long-term studies.

RHEUMATOLOGY NEWS and “The Pink Sheet” are published by Elsevier.

A Food and Drug Administration panel has recommended that the agency approve etanercept for moderate to severe plaque psoriasis in pediatric patients; however, some members expressed concern over labeling for moderate psoriasis, preferring that the FDA approve the product for severe cases only.

The Dermatologic and Ophthalmic Drugs Advisory Committee voted 8-5, saying that the drug manufacturer (Amgen Inc.) provided sufficient information to demonstrate the safety and efficacy of etanercept (Enbrel) in the pediatric population with severe psoriasis. But members noted a lack of data on long-term adverse events and maintenance of the treatment effect. The outside medical experts also were divided over whether the tumor necrosis factor blocker's risks outweighed its benefits for patients with moderate psoriasis.

The FDA presented data showing the product's adverse events, including life-threatening infections and malignancies. Amgen's senior vice president for global regulatory affairs and safety, Paul Eisenberg, acknowledged that the benefit and risk have not been established beyond 1 year in the pediatric population.

Nevertheless, the panel moved to give physicians the option of prescribing the product. Consumer representative Mary Majumder said, “Nobody wants this to be used widely, and nobody wants it never to be used.”

Enbrel already is used off label for the proposed indication, and Amgen intends to continue gathering clinical data on the indication, which helped sway committee members to vote in its favor.

The company said it will target several thousand pediatric patients, aged 4-17 years, over the next few years in proposed postmarketing studies, including a prospective long-term safety registry with a minimum 5-year follow-up. It also plans to extend its current 3-year open-label extension study to 5 years.

The same committee unanimously voted in favor of approving Centocor Inc.'s ustekinumab recently, also calling for additional long-term studies.

RHEUMATOLOGY NEWS and “The Pink Sheet” are published by Elsevier.

Companies marketing unapproved drugs that contain injectable colchicine to treat gout have 30 days to stop manufacturing and 180 days to stop shipping the drug, which has caused 23 reported deaths, according to the U.S. Food and Drug Administration.

All injectable colchicine drugs on the market 180 days after the FDA's announcement on Feb. 6 must have the agency's approval. Refusal could result in regulatory action, including seizure, injunction, or other legal action, according to the FDA statement. The enforcement measure marks the seventh action taken by the agency against companies marketing and selling unapproved drugs since issuing its Compliance Policy Guide. Colchicine tablets will remain on the market for now.

Injectable colchicine has been approved for treatment of gout in the U.S. since the 1950s. It is rarely administered because its use results in harmful adverse events or death.

For more information on the FDA's action, please go to http://www.fda.gov/cder/drug/unapproved_drugs/colchicine_qa.htm

RHEUMATOLOGY NEWS and “The Pink Sheet” are published by Elsevier.

Companies marketing unapproved drugs that contain injectable colchicine to treat gout have 30 days to stop manufacturing and 180 days to stop shipping the drug, which has caused 23 reported deaths, according to the U.S. Food and Drug Administration.

All injectable colchicine drugs on the market 180 days after the FDA's announcement on Feb. 6 must have the agency's approval. Refusal could result in regulatory action, including seizure, injunction, or other legal action, according to the FDA statement. The enforcement measure marks the seventh action taken by the agency against companies marketing and selling unapproved drugs since issuing its Compliance Policy Guide. Colchicine tablets will remain on the market for now.

Injectable colchicine has been approved for treatment of gout in the U.S. since the 1950s. It is rarely administered because its use results in harmful adverse events or death.

For more information on the FDA's action, please go to http://www.fda.gov/cder/drug/unapproved_drugs/colchicine_qa.htm

RHEUMATOLOGY NEWS and “The Pink Sheet” are published by Elsevier.

Companies marketing unapproved drugs that contain injectable colchicine to treat gout have 30 days to stop manufacturing and 180 days to stop shipping the drug, which has caused 23 reported deaths, according to the U.S. Food and Drug Administration.

All injectable colchicine drugs on the market 180 days after the FDA's announcement on Feb. 6 must have the agency's approval. Refusal could result in regulatory action, including seizure, injunction, or other legal action, according to the FDA statement. The enforcement measure marks the seventh action taken by the agency against companies marketing and selling unapproved drugs since issuing its Compliance Policy Guide. Colchicine tablets will remain on the market for now.

Injectable colchicine has been approved for treatment of gout in the U.S. since the 1950s. It is rarely administered because its use results in harmful adverse events or death.

For more information on the FDA's action, please go to http://www.fda.gov/cder/drug/unapproved_drugs/colchicine_qa.htm