The drug is a potential new treatment for type 1 diabetes.
Sanofi’s application to the European Medicines Agency (EMA) for review of sotagliflozin has been accepted. Sotagliflozin is a dual inhibitor of SGLT-1 and SGLT-2 proteins, which influence how the intestines and kidneys process glucose. It is an oral treatment that, when used in conjunction with insulin therapy, improves blood sugar control in adults with type 1 diabetes mellitus. Sanofi developed the drug in collaboration with Lexicon Pharmaceuticals, Inc.
The Marketing Authorization Application submitted to EMA by Sanofi was based on the results of a phase 3 study comprising approximately 3,000 adults with inadequately controlled type 1 diabetes. The trial was designed to evaluate the safety and efficacy of sotagliflozin.
Noted Sanofi’s Senior-Vice President and Global Head of Development Jorge Insuasty: Despite recent advances, the challenges of type 1 diabetes management prevent many patients from reaching their treatment goals. There is a need for therapies to be used in addition to insulin to help people with type 1 diabetes better control their blood sugar. Sotagliflozin is the first SGLT-1/2 dual inhibitor to be accepted for regulatory review in Europe. We look forward to working with the EMA through the review process to bring this potential treatment to patients."