FDA Advisory Committee recommends metreleptin for Lipodystrophy -AstraZeneca/BMS

AstraZeneca and BMS announced that the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommends the investigational medicine metreleptin for the treatment of paediatric and adult patients with Generalized Lipodystrophy (LD). Specifically, EMDAC determined by a vote of 11 to 1 that there is substantial evidence that the benefits of metreleptin exceed the risks for the treatment of paediatric and adult patients with generalized lipodystrophy.EMDAC did not recommend metreleptin in patients with partial LD for the indication currently proposed, by a vote of 2 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.

The desired and wider indication of metabolic disorders associated with partial lipodystrophy was not recommended instead the recommendation is for the narrower indication of patients with generalised LD- a complete loss of leptin which is a small group of patients.