Sotagliflozin NDA Submitted to FDA for Type 1 Diabetes
Sanofi, in collaboration with Lexicon Pharmaceuticals, has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for sotagliflozin, an investigational dual sodium-glucose co-transporter types 1 and 2 (SGLT1, SGLT2) inhibitor, intended for use with insulin to improve glycemic control in adults with type 1 diabetes.
Sotagliflozin works by inhibiting the two proteins responsible for glucose regulation: SGLT1 (responsible for glucose absorption in the GI tract) and SGLT2 (responsible for glucose reabsorption by the kidney).
The NDA is based on results from a large placebo-controlled, Phase 3 trial that included 1,402 patients with type 1 diabetes who were receiving insulin therapy. Results from the trial showed that a significantly larger proportion of patients in the sotagliflozin group (28.6%) achieved the primary endpoint (glycated hemoglobin level <7.0% at week 24, with no episodes of severe hypoglycemia or diabetic ketoacidosis) than the placebo group (15.2%).
“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.
For more information visit nejm.org.