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Lexicon Announces FDA Acceptance of New Drug Application for Sotagliflozin to Treat Heart Failure
NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program Evaluating Sotagliflozin in Almost 12,000 People THE WOODLANDS, Texas, July 27, 2022 (GLOBE
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"NDA supported by SOLOIST-WHF and SCORED Global Phase 3 Program Evaluating Sotagliflozin in Almost 12,000 People\nTHE WOODLANDS, Texas, July 27, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and filed its New Drug Application (NDA) for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, for the treatment of heart failure. The FDA assigned a standard review for the NDA filing with a Prescription Drug User Fee Act (PDUFA) target action date in May 2023. “This is an important step in potentially bringing sotagliflozin to market as a new treatment for heart failure,” said Lonnel Coats, Lexicon’s chief executive officer. “Informed by our regulatory discussions, we are seeking a broad heart failure label in the NDA encompassing heart failure patients with and without diabetes, and believe that the results of SOLOIST-WHF in patients admitted for recent worsening heart failure will be an important element distinguishing our proposed label. We look forward to engaging with the FDA during the review process to bring this potential new treatment to market by the middle of next year.” The NDA is supported by the results from the Phase 3 SOLOIST-WHF clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease. In the NDA, Lexicon is seeking that sotagliflozin be indicated to: Reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure, including those with acute or worsening heart failure.Reduce the risk of cardiovascular death, hospitalization for heart failure, urgent heart failure visit, nonfatal myocardial infarction, and nonfatal stroke in adults with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors, including a history of heart failure. About the SOLOIST-WHF and SCORED Studies SOLOIST-WHF was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 people with type 2 diabetes who had recently...