Path forward for sotagliflozin becomes clear after FDA feedback

12 March 2024

Following discussions with the US regulator, Texan drugmaker Lexicon Pharmaceuticals (Nasdaq: LXRX) now plans to resubmit a New Drug Application (NDA) for sotagliflozin.

The firm announced that, after the receipt of recent feedback from US Food and Drug Administration, the new submission would be completed by mid-2024.

Lexicon is submitting for approval to market sotagliflozin as an adjunct to insulin for glycemic control in people with type 1 diabetes and chronic kidney disease.

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