Sanofi’s Sotagliflozin Accepted for Review by EMA

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."


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.