FDA Accepts Lexicon's New Drug Application For Review In Heart Failure Setting

FDA Accepts Lexicon's New Drug Application For Review In Heart Failure Setting

The U.S. Food and Drug Administration (FDA) has accepted for review Lexicon PharmaceuticalsLXRX New Drug Application (NDA) for sotagliflozin for the treatment of heart failure.

The regulatory agency has assigned a standard review with a PDUFA target action date in May 2023.

The regulatory submission is supported by the data readout 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.

Lonnel Coats, Chief executive officer, commented: "This is an important step in potentially bringing sotagliflozin to market as a new treatment for heart failure, 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.”

The company is planning for commercial launch of the drug by the middle of next year.

Price Action : Lexicon shares are trading higher at $3.14 on Wednesday at the time of publication.

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