Lexicon Pharmaceuticals announced that its collaborator, Sanofi, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration 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.

“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.”

“With approximately three-quarters of adult patients in the U.S. with type 1 diabetes not reaching their A1C goals, sotagliflozin would represent an important advance in managing these patients,” said Anne Peters, M.D., Professor of Medicine at the Keck School of Medicine of USC, director of the USC Clinical Diabetes Programs and chairman of the Sotagliflozin Type 1 Diabetes Steering Committee. “It potentially will be the first oral agent in the U.S. to be used in combination with insulin to improve glycemic control and patient outcomes.”