Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults With Type 1 Diabetes

Lexicon Pharmaceuticals (Nasdaq:LXRX) announced that its collaborator, Sanofi, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

As quoted in the press release:

“The NDA and MAA submissions for sotagliflozin represent important milestones for Lexicon and for people in the United States and Europe who are living with the challenges of type 1 diabetes,” said Pablo Lapuerta, M.D., executive vice president and chief medical officer. “These filings highlight our strong investment in internally discovered therapies and are a culmination of the largest Phase 3 program for an oral anti-diabetic agent ever conducted in type 1 diabetes, in the broadest range of patients, resulting in the most comprehensive efficacy and safety database. I am extremely proud of our team members who have worked tirelessly to achieve this step towards bringing this important potential therapy to patients with type 1 diabetes.”

Click here to read the full press release.