30 December 2021 - ) -- Lexicon Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA seeking approval for the marketing and sale of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction.

The submission is supported by the results from the Phase 3 SOLOIST clinical trial in patients with type 2 diabetes who had recently been hospitalised for worsening heart failure and the Phase 3 SCORED clinical trial in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.

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