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FDA panel rebuffs lorcaserin

September 17, 2010 12:32 AM UTC

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 While panel members agreed that lorcaserin had met the efficacy criteria outlined in draft guidance for obesity candidates published by FDA in 2007, the majority of panelists felt that the efficacy was modest and did not outweigh the potential safety risks.

Panelists were concerned by the increased rate of mammary tumors in female rats and the exclusion of patients with certain co-morbid conditions like diabetes. Panel members felt that the patients enrolled in the Phase III trials were healthier than those that would be taking lorcaserin if it were approved. Arena has a Phase III trial in patients with Type II diabetes ongoing, with data expected at year end. The serotonin (5-HT2C) receptor agonist has an Oct. 22 PDUFA date. Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) has marketing rights to lorcaserin in the U.S. ...