Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes

Core Viewpoint - Lexicon Pharmaceuticals has resubmitted its New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD) following feedback from the U.S. Food and Drug Administration (FDA) [1][3][10] Group 1: Regulatory Developments - The company anticipates a six-month review period from the FDA and a potential product launch in early 2025 [3] - The NDA for sotagliflozin was previously met with a complete response letter (CRL) from the FDA in 2019, and subsequent discussions led to the current resubmission [10] - The application remains in "filed" status at the FDA, with a formal communication expected within 30 days to establish the action date [10] Group 2: Company Insights - Lexicon Pharmaceuticals is focused on pioneering medicines that transform patients' lives, utilizing its Genome5000™ program to identify therapeutic targets [7] - The company has successfully launched INPEFA® (sotagliflozin) in the U.S. and is developing additional drug candidates for various indications [7] - The CEO expressed confidence in the benefit/risk profile of sotagliflozin for patients with type 1 diabetes and CKD, emphasizing the importance of this therapy [6]