FDA accepts supplemental New Drug Application to expand lorcaserin label


The Food and Drug Administration has accepted a supplemental New Drug Application from Eisai to update the label for the weight-loss drug lorcaserin (Belviq) with long-term efficacy and safety data from the CAMELLIA-TIMI 61 trial.

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In CAMELLIA-TIMI 61, a double-blind, placebo-controlled, parallel-group, phase 3b/4 clinical trial, about 12,000 people who were overweight or obese and had cardiovascular disease or CVD risk factors, such as type 2 diabetes, received lorcaserin or placebo. In a study published in the New England Journal of Medicine last fall, lorcaserin, a serotonin 2C receptor agonist, met the primary safety endpoint of noninferiority to placebo in the rate of major adverse cardiovascular events (hazard ratio, 0.99; 95% confidence interval, 0.85-1.14; P less than .001).

After meeting the primary endpoint, the trial investigators continued the study, assessing for a broader composite endpoint consisting of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization caused by unstable angina, heart failure, or coronary revascularization. Although lorcaserin was not superior to placebo in this expanded study, it remained noninferior.

Lorcaserin is contraindicated in women who are pregnant and in patients hypersensitive to lorcaserin. The most common adverse events in patients without diabetes were headache, dizziness, fatigue, nausea, dry mouth, and constipation; in patients with diabetes, the most common adverse events were hypoglycemia, headache, back pain, cough, and fatigue.

“This sNDA file acceptance brings us one step closer to potentially incorporating data into our label based on the first completed large-scale cardiovascular outcomes trial for a weight loss agent,” Lynn Kramer, MD, chief clinical officer and chief medical officer of the Neurology Business Group at Eisai, said in the press release.

Find the full press release on the Eisai website.

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