Lexicon Refiles FDA Application for Sotagliflozin in Heart Failure

By Colin Kellaher

Lexicon Pharmaceuticals Inc. on Tuesday said it has resubmitted its application seeking U.S. Food and Drug Administration approval of sotagliflozin for the treatment of heart failure.

Lexicon, based in The Woodlands, Texas, voluntarily withdrew the application in February to correct a technical issue.

Lexicon had been seeking FDA approval of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent visits for heart failure in adults with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction.

Lexicon said the FDA now has 60 days to determine whether the application is complete and acceptable for filing, adding that it plans to work closely with the agency during the review process.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 31, 2022 08:27 ET (12:27 GMT)

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