Mixed FDA advisory panel votes on Bristol-Myers and AstraZeneca's metreleptin

In an 11 to one vote yesterday, the US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended the investigational drug metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD), from USA drug major Bristol-Myers Squibb (NYSE: BMY) and partner Anglo-Swedish pharma company AstraZeneca (LSE: AZN).

Specifically, EMDAC determined that there is substantial evidence that the benefits of metreleptin exceed the risks for the treatment of pediatric and adult patients with generalized lipodystrophy.

However, the EMDAC did not recommend metreleptin in patients with partial LD for the indication currently proposed, by a vote of two to 10. AstraZeneca and Bristol-Myers Squibb remain committed to pursuing metreleptin for treatment in patients with metabolic disorders associated with partial LD. The Companies acknowledge the committee’s feedback and will continue to work with the FDA to identify the appropriate patients with partial LD who may benefit from metreleptin.