FDA advisory panel partially backs Bristol-Myers drug for rare fat disorder


An FDA advisory panel says Bristol-Myers Squibb (BMY -0.1%) had provided adequate evidence of the benefits of the metreleptin experimental drug to treat rare and potentially fatal disorders involving loss of body fat.

However 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.

BMY and co-developer AstraZeneca(AZN +0.3%) say they are confident in the safety and efficacy data provided to the agency for both indications discussed by the panel.

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