EMA accepts marketing authorisation submission for type 1 diabetes treatment

The European Medicines Agency (EMA) has accepted Sanofi’s regulatory submission for sotagliflozin, a potential treatment for type 1 diabetes, for review.

Sotagliflozin, which was developed in partnership with Lexicon Pharmaceuticals, is an investigational dual inhibitor of SGLT-1 and SGLT-2 — proteins that influence how the intestines and kidneys process blood sugar. If sotagliflozin is approved it will be used in addition to insulin therapy to improve blood sugar control in adult patients suffering from type 1 diabetes mellitus.

“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,” said Jorge Insuasty, Senior-Vice President, Global Head of Development, Sanofi. “We look forward to working with the EMA through the review process to bring this potential treatment to patients.”

This marketing authorisation submission has been based on data from the inTandem clinical trial programme — three Phase III clinical trials assessing the safety and efficacy of sotagliflozin in about 3,000 adults. The drug’s safety and efficacy have not been fully evaluated by any regulatory authority.