FDA Panel Accepts Metreleptin For Generalized Lipodystrophy, No Further Criteria Needed
This article was originally published in The Pink Sheet Daily
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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AstraZeneca has declined an option agreement from Bristol-Myers Squibb on Indian drug maker Biocon’s oral insulin, raising questions about the fate of the candidate Biocon hopes will be a blockbuster.
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.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.