Sanofi: EMA To Review Regulatory Submission For Sotagliflozin - Quick Facts

(RTTNews) - Sanofi (SNYNF, SNY) announced the European Medicines Agency has accepted for review the company's regulatory submission for sotagliflozin. If approved, the oral treatment would be used as an addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes mellitus. The Marketing Authorization Application submitted to EMA is based on data from the inTandem clinical trial program which consists of three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled type 1 diabetes.

Developed in partnership with Lexicon Pharmaceuticals, Inc., sotagliflozin is an investigational dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys process blood sugar.