Home » FDA Panel Splits on Sanofi’s Diabetes NDA
FDA Panel Splits on Sanofi’s Diabetes NDA
January 24, 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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