26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA.

Lexicon Pharmaceuticals today announced that its collaborator, Sanofi, has submitted a New Drug Application to the U.S. FDA and a marketing authorisation application to the EMA for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for use in combination with insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.

Lexicon entered into a collaboration and license agreement with Sanofi in November 2015 under which Lexicon granted Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. Lexicon is responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the U.S. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide (excluding Japan) and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the U.S. (excluding Japan).

Read Lexicon Pharmaceuticals press release