FDA panel backs metreleptin for generalized lipodystrophy

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11-1 that the Amylin Pharmaceuticals Inc. subsidiary of Bristol-Myers Squibb Co. (NYSE:BMY) provided substantial evidence that the benefits of Myalept metreleptin exceed the risks in patients with generalized lipodystrophy. However, the panel voted 10-2 that the benefits of metreleptin did not exceed the risks in patients with metabolic disorders associated with partial lipodystrophy. Bristol-Myers has proposed a REMS for metreleptin that would include a physician and pharmacy certification component, as well as a prescriber education program and a metreleptin safety registry. Metreleptin is under Priority Review for the indications, with a Feb. 24 PDUFA date. ...