Benzinga | Dec 30, 2021 04:08PM EST

Lexicon Submits New Drug Application For Sotagliflozin For Treatment Of Heart Failure In Adults With Type 2 Diabetes

Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration 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 FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.



"The submission of the NDA for sotagliflozin brings us one step closer to the possibility of bringing this innovative new investigational treatment to those who are suffering from heart failure and living with type 2 diabetes on a daily basis," said Lonnel Coats, Lexicon's chief executive officer. "We look forward to working closely with the FDA during the review process."

The NDA submission is supported by the results from the Phase 3 SOLOIST 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.