LX 4211 filed with EMA for type 1 diabetes.- Sanofi.
The European Medicines Agency (EMA) has accepted for review Sanofi's regulatory submission for LX 4211 (sotagliflozin) in type 1 diabetes. 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. 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 (glucose).
The Marketing Authorization Application submitted to EMA is based on data from the inTandem clinical trial program which consists of three Phase III clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled type 1 diabetes. Its safety and efficacy have not been fully evaluated by any regulatory authority.
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