Lorcaserin regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 19-4 that the benefit-risk profile for lorcaserin from Arena supports approval to treat obesity. Panel members were not impressed by lorcaserin's efficacy, but felt that the compound did meet the criteria outlined in FDA's 2007 draft guidance. The guidance states that new agents should demonstrate more than a 5% placebo-adjusted weight loss from baseline, or show that at least twice as many patients in the treatment arm lost at least 5% of body weight. In a pooled analysis of Phase III results, the mean placebo-adjusted weight loss for lorcaserin was 3.3% and about 47% of patients on lorcaserin lost at least 5% of baseline body weight vs. 23% for placebo.

However, the panel expressed concerned about the increased risk of valvulopathy and recommended a postmarketing cardiovascular outcomes trial and a REMS program. The program includes baseline and at least annual echocardiograms to monitor for valvulopathy. Arena did not present any information about a potential REMS or postapproval outcomes at the meeting or in briefing documents. ...