FDA advisory panel partially backs drug for rare fat disorder

(Reuters) – An advisory panel of medical experts convened by the U.S. Food and Drug Administration on Wednesday said that Bristol-Myers Squibb Co had provided adequate evidence of the benefits of an experimental drug to treat rare and potentially fatal disorders involving loss of body fat. The panel voted 11-1 that the benefits of the drug metreleptin outweigh the risks for the treatment of children and adults suffering from a condition known as generalized lipodystrophy. Only a few thousand people worldwide are believed to have the disorders, in which fat builds up in the blood and organs such as liver and muscle, and can lead to diabetes, pancreatitis and fatty liver disease. However, by a 10-2 vote, the panel felt the risks of the medicine were too high to recommend it for metabolic disorders associated with partial lipodystrophy, such as diabetes and high triglycerides inadequately controlled by a current therapy.