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Sanofi's Oral Type 1 Diabetes Drug Approval May Hinge On Ketoacidosis Management

 
• By Derrick Gingery

US FDA also questions composite efficacy endpoint used in one of the phase III trials as sotagliflozin reaches advisory committee in attempt to become first approved oral type 1 diabetes treatment. Sanofi says that type 1 diabetes patients already manage DKA risk because it is inherent to their condition and patients did not seem bothered by the instructions to handle DKA.

FDA Advisory Committee Feature image

Sanofi is looking to move SGLT1 and SGLT2 inhibitors into type 1 diabetes with its sotagliflozin, but first will have to overcome the US FDA's worries about the risk of diabetic ketoacidosis.

Sotagliflozin, expected trade name Zynquista, is proposed as an oral adjunct to insulin to improve glycemic control in adults with type 1 diabetes

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