Posted by Michael Wonder on 27 Jul 2022
Lexicon announces FDA acceptance of new drug application for sotagliflozin to treat heart failure
27 July 2022 - NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program evaluating sotagliflozin in almost 12,000 people.
Lexicon Pharmaceuticals today announced that the U.S. FDA has accepted for review and filed its new drug application for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of heart failure.
The FDA assigned a standard review for the filing with a Prescription Drug User Fee Act target action date in May 2023.
