BRIEF—Lexicon Pharmaceuticals resubmits sotagliflozin NDA

US drugmaker Lexicon Pharmaceuticals today announced that, following multiple interactions with and recent feedback from the US Food and Drug Administration (FDA), it has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with type 1 diabetes and chronic kidney disease (CKD).

In 2019, the FDA issued a complete response letter (CRL) regarding the NDA for sotagliflozin for type 1 diabetes. In 2021, at Lexicon’s request, the FDA issued a public Notice of Opportunity for Hearing (NOOH) on whether there were grounds for denying such approval.

Lexicon and FDA subsequently agreed in late 2023 to hold the NOOH proceedings in abeyance in order to engage in discussions regarding a path forward for resubmission and potential approval of the NDA.