FDA issues Complete Response Letter for Zynquista™ (sotagliflozin)
The FDA issued a CRL regarding the NDA for investigational Zynquista™ (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin. Sanofi and Lexicon will work closely with the FDA to determine the appropriate next steps. March 22, 2019