FDA Goes To Committee With Uncertainty About Metreleptin Efficacy For Partial Lipodystrophy
This article was originally published in The Pink Sheet Daily
The Dec. 11 Endocrinologic and Metabolic Drugs Advisory Committee also will consider whether a proposed Risk Evaluation and Mitigation Strategy would address the possible risk for lymphoma and immunogenicity with Bristol-Myers Squibb/AstraZeneca’s drug.
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Agency clears Amylin’s metreleptin, expands the use of Vertex’s Kalydeco and approves a novel formulation of indomethacin from Iroko, and Pfizer’s Prevnar 13 moves closer to getting a CDC recommendation to match its FDA approval for use in older adults.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of the Bristol/AstraZeneca drug to treat generalized lipodystrophy but rejected the proposed partial lipodystrophy indication as too broad.
Members of the Endocrinologic and Metabolic Drugs Advisory Committee say there is no data to support limiting Bristol-Myers Squibb/AstraZeneca’s drug to a subpopulation.