FDA Update: Sotagliflozin Approved For Broad HF Treatment

The U.S. Food and Drug Administration (FDA) on May 26 approved a new drug application submitted by Lexicon Pharmaceuticals, Inc. for sotagliflozin (Inpefa), the first dual SGLT1 and SGLT2 inhibitor for the treatment of heart failure (HF), including HF with preserved ejection fraction and HF with reduced ejection fraction.

The once-daily oral tablet is approved to reduce the risk of cardiovascular death, hospitalization for HF, and urgent HF visits in adult patients with HF or type 2 diabetes mellitus, chronic kidney disease and other cardiovascular risk factors. Approval was based on phase 3 results from the SCORED trial and the SOLOIST-WHF trial, the latter of which were presented at ACC.23/WCC in New Orleans.  

Lexicon expects the new drug to be available by the end of June 2023. For more information, access the FDA approval letter or the Lexicon press release.

Clinical Topics: Cardiovascular Care Team, Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Acute Heart Failure

Keywords: Tablets, Hospitalization, Renal Insufficiency, Chronic, Ventricular Dysfunction, Left, Heart Failure, Risk Factors, Cardiovascular Diseases, Consensus, United States Food and Drug Administration, Sodium-Glucose Transporter 2, Diabetes Mellitus, Type 2, Stroke Volume, Sodium-Glucose Transporter 2 Inhibitors, ACC Advocacy

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