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Sanofi, Lexicon Pharmaceuticals seek approval for diabetes drug in US, Europe

Sanofi filed a new drug application to the U.S. Food and Drug Administration and a marketing authorization application to the European Medicines Agency for its diabetes drug sotagliflozin.

The company is seeking approval for the drug for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. Results of a phase 3 trial previously showed that sotagliflozin was better than placebo at treating type 1 diabetes.

Sanofi and Lexicon Pharmaceuticals Inc. are jointly developing the drug under a collaboration and license agreement signed in November 2015.