12:00 AM
May 14, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

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were not impressed by lorcaserin's efficacy, but felt that the compound did meet the criteria outlined in FDA's 2007 draft guidance.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...

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