DKA concerns remain paramount in FDA’s denial of sotagliflozin for type 1 diabetes
For the second time since 2019, the oral SGLT1 and SGLT2 dual inhibitor sotagliflozin has been denied FDA approval for adults with type 1 diabetes, with elevated risk for diabetic ketoacidosis being a primary concern.Lexicon Pharmaceuticals acknowledged the receipt of an FDA complete response letter for sotagliflozin (Zynquista, Lexicon) in a press release on Dec. 20. The company had filed a new