Lorcaserin regulatory update

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 9-5 that the benefit-risk profile of Arena's lorcaserin did not support approval to treat obesity. While panel members agreed that lorcaserin had met the efficacy criteria outlined in draft guidance for obesity candidates published by FDA in 2007, the majority of panelists felt that the efficacy was modest and did not outweigh the potential safety risks. ...