FDA Approves Lexicon’s INPEFA (sotagliflozin) Daily Pill For treatment of Heart Failure

June 13, 2023

On May 26, 2023, Lexicon Pharmaceuticals’ INPEFA (sotagliflozin) was approved by the US FDA with broad label uses for treatment of heart failure. Heart failure is a significant, debilitating condition where the heart does not deliver enough oxygen to the cells in the body. It affects over 6 million Americans and hospitalizes over a million Americans per year. INPEFA has been shown to reduce cardiovascular death, hospitalization, and urgent heart failure by 33% when compared with placebo. It is approved in patients with left ventricular ejection fraction (LVEF) and for adults with cardiovascular risk factors, including type 2 diabetes and chronic kidney disease. INPEFA is a sodium-glucose cotransporter inhibitor and affects glucose regulation. Jacksonville Center for Clinical Research participated in the SOLOIST and SCORED clinical trials which were critical in showing the effectiveness of INPEFA. Lexicon expects INPEFA to be available by the end of June, 2023.

Source: https://www.lexpharma.com/media-center/news/2023-05-26-lexicon-announces-fda-approval-of-inpefa-sotagliflozin-for-treatment-of-heart-failure

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