FDA advisory committee recommends approval for Bristol-Myers Squibb's, AstraZeneca's metreleptin in generalized lipodystrophy

Committee does not recommend approval of drug for partial LD-associated disorders

PRINCETON, N.J. — A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.

The drug makers said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11-1 to recommend that the agency approve metreleptin for treating children and adults with generalized lipodystrophy, also known as LD. LD disorders cause severe metabolic abnormalities and significant morbidity and death. The FDA is not required to follow the votes of advisory committees when considering whether to approve a drug, but it usually does.

However, the committee did not vote in favor of recommending the drug for patients with metabolic disorders associated with partial LD, though the companies said they would continue to push for approval for that usage.

 

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