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# Lexicon Wins Approval for Heart Failure Drug
- URL: https://www.fdaweb.com/lexicon-wins-approval-for-heart-failure-drug/
- Published: 2023-05-26T12:00:00.000Z
- Updated: 2026-09-14T18:34:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154560

FDA has approved a Lexicon Pharmaceuticals NDA for Inpefa (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or Type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The approval is based on two Phase 3 cardiovascular outcomes studies in 12,000 patients with heart failure or at risk of heart failure. Data showed that Inpefa “significantly reduced risk of the composite of hospitalizations for heart failure, urgent visits for heart failure, and cardiovascular death by 33% compared to placebo in patients who had been recently hospitalized for worsening heart failure,” the company says.

The dual SGLT1 and SGLT2 inhibitor has had a troubled past. In 2019, CDER issued a complete response letter to Sanofi/Lexicon stating that the NDA could not be approved because its clinical data demonstrated that the addition of sotagliflozin to insulin was associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency. Two subsequent dispute resolution requests were rejected by CDER based on the determination that the drug’s DKA risk outweighed its benefits.

Lexicon says that a new analysis evaluating the clinical benefit of sotagliflozin in heart failure and blood glucose control across the full range of kidney function was presented at the American Heart Association Scientific Sessions in 2020\. Subsequently, the SGLT inhibitor class was recommended as first-line treatment for heart failure by the American Heart Association, the American College of Cardiology, and the Heart Failure Society of America in a joint 2022 Guideline for the Management of Heart Failure, it says.