LXRX - Lexicon refiles for FDA approval of sotagliflozin to treat heart failure

Lexicon Pharmaceuticals (NASDAQ:LXRX) said it resubmitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of sotagliflozin to treat heart failure. The company said the FDA has a 60-day filing review period to determine if the NDA is complete and acceptable for filing. The DA is backed by data from a phase 3 trials called — SOLOIST-WHF in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure; and SCORED in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease. "We believe sotagliflozin’s dual SGLT1 and SGLT2 mechanism and the data from our SOLOIST-WHF and SCORED Phase 3 trials address important areas of need in the treatment of heart failure," said Lexicon’s CEO Lonnel Coats. LXRX +3.45% to $1.80 premarket May 31

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Lexicon refiles for FDA approval of sotagliflozin to treat heart failure