LXRX - Lexicon announces FDA review of heart failure therapy

• Clinical-stage biotech Lexicon Pharmaceuticals ( NASDAQ: LXRX ) announced on Wednesday that the FDA accepted its New Drug Application (NDA) for sotagliflozin, an experimental therapy targeted at heart failure. The regulator has granted a standard review for the NDA with a PDUFA date in May 2023.
• FDA has rejected its approval in several occasions, previously.
• Lexicon ( LXRX ) is expecting a broad label for the NDA to target heart failure patients with and without diabetes, Chief Executive Lonnel Coats said, noting that results from the company’s Phase 3 SOLOIST-WHF study would be critical in supporting the proposed label.
• “This is an important step in potentially bringing sotagliflozin to market as a new treatment for heart failure,” Coats noted.
• In May, Lexicon ( LXRX ) announced the refiling of the NDA for sotagliflozin after the FDA rejected it for type 1 diabetes in 2019.

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