Jan
13
2025
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 drug application for sotagliflozin to improve glucose control as an adjunct to insulin for adults with type 1 diabetes and chronic kidney disease in July.
In its Dec. 20 press release, Lexicon
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