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.
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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.
Discussions between FDA and researchers during a workshop on the fatty liver conditions NAFLD/NASH clarified the status of potential surrogate endpoints for clinical trials, but indicated that much work remains to be done to ready the various options for use – and that will likely need to be a joint effort.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.