Sanofi's Sotagliflozin: Risk Of Ketoacidosis Divides US FDA Advisory Committee

Some Endocrinologic and Metabolic Drugs Advisory Committee members said a REMS is sufficient, but others worried that proposed risk management plans were not proven effective.

FDA Advisory Committee Feature image

US FDA advisory committee members split on whether Sanofi and Lexicon Pharmaceuticals Inc.'s proposed type 1 diabetes treatment sotagliflozin should be approved amid questions about how to manage the risk of diabetic ketoacidosis.

The 8-8 vote by the Endocrinologic and Metabolic Drugs Advisory Committee Jan

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from US FDA Performance Tracker

More from Regulatory Trackers