Lexicon’s Once-a-Day Tablet to Reduce Risks of Heart Failure Gets FDA Approval

The FDA has approved Lexicon Pharmaceutical’s Inpefa, a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

The broad label encompasses heart failure patients across the full range of left ventricular ejection fraction (LVEF), including preserved ejection fraction and reduced ejection fraction, and for patients with or without diabetes.

Heart failure is the leading cause of hospitalizations for individuals aged 65 and older, triggering approximately 1.3 million hospitalizations a year. Patients with heart failure are at highest risk of a heart failure event in the first 30 days post-discharge, with 7 percent dying and 25 percent being rehospitalized within one month, the company said.

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