Lexicon preparing to resubmit sotagliflozin NDA mid-year

Lexicon Pharmaceuticals announced that, following the receipt of recent feedback from FDA, it is preparing to resubmit its New Drug Application for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease. The resubmission is planned for mid-year, with an anticipated six-month regulatory review period. FDA issued a complete response letter regarding the NDA for sotagliflozin for type 1 diabetes in 2019 and, at Lexicon’s request, issued a public Notice of Opportunity for Hearing in 2021 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.