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FDA Goes To Committee With Uncertainty About Metreleptin Efficacy For Partial Lipodystrophy

This article was originally published in The Pink Sheet Daily

Executive Summary

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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Metreleptin Needs Tighter Partial Lipodystrophy Indication, Panel Says

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.

FDA Panel Accepts Metreleptin For Generalized Lipodystrophy, No Further Criteria Needed

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.

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