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FDA advisory committee votes on AstraZeneca PLC and Bristol-Myers Squibb Co investigational medicine metreleptin


Wednesday, 11 Dec 2013 09:49pm EST 

AstraZeneca PLC and Bristol-Myers Squibb Co:Says the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommends the investigational medicine metreleptin for the treatment of pediatric and adult patients with generalized lipodystrophy (LD).Says EMDAC determined by a vote of 11 to 1 that there is evidence that the benefits of metreleptin exceed the risks for the treatment of pediatric and adult patients with generalized lipodystrophy.Says EMDAC did not recommend metreleptin in patients with partial LD for the indication currently proposed, by a vote of 2 to 10.Says they remain committed to pursuing metreleptin for treatment in patients with metabolic disorders associated with partial LD. 

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