Full Press Release Details
EMA to review sotagliflozin as potential treatment for type 1 diabetes
Paris March 29, 2018 The European Medicines Agency (EMA) has accepted for review Sanofi 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. 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).
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, says 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.
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.1 3 Its safety and efficacy have not been fully evaluated
by any regulatory authority.
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with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
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solutions around the globe.
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