Advisory committee votes in favor of lorcaserin

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 18-4, with one abstention, that the benefit-risk profile for lorcaserin from Arena Pharmaceuticals Inc. (NASDAQ:ARNA) 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were not impressed by lorcaserin's efficacy, but felt that the compound did meet the criteria outlined in FDA's 2007 draft guidance.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. ...