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Pharmaceuticals / Regulatory Affairs

FDA Panel Splits on Sanofi’s Diabetes NDA

Jan. 25, 2019

An FDA advisory committee deadlocked on the safety profile for Sanofi’s NDA for type 1 diabetes drug sotagliflozin.

The Endocrinologic and Metabolic Drugs Advisory Committee considered the drug’s safety as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes. The committee’s vote was 8-8.

Dan Budnitz, director of the Centers for Disease Control and Prevention’s Medication Safety Program, voted in favor of the drug’s safety profile, but said that the FDA should require a Risk Evaluation and Mitigation Strategy to ensure patient use mimics clinical trial conditions.

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