Following a Priority Review designation for finerenone in March, The U.S. Food and Drug Administration (FDA) just announced their approval of Bayer’s Kerendia (finerenone) for the treatment of adult patients with heart failure and a left ventricular ejection fraction (LVEF) of ≥40%.
Previously, Kerendia (finerenone) received FDA approval in 2021 for the treatment of patients with chronic kidney disease. This second, new approval marks Kerendia as the only non-steroidal mineralocorticoid receptor antagonist approved in the United States for chronic kidney disease that is associated with type 2 diabetes and heart failure with LVEF of ≥40%.
Millions of people in the United States live with heart failure, accounting for hundreds of thousands of hospitalizations each year. Finerenone’s approval follows the successes recorded in the Phase III FINEARTS-HF study, which is a component of Bayer’s larger MOONRAKER program, one of the largest initiatives focused on heart failure, with more than 15,000 patients enrolled.
Guidelines Related To This Topic
- Management of Heart Failure
- American College of Cardiology/American Heart Association/Heart Failure Society of America
- Treatment of Heart Failure with Reduced Ejection Fraction
- American College of Cardiology
- Management of Heart Failure with Preserved Ejection Fraction
- American College of Cardiology
We look forward to seeing how this FDA approval affects clinical guidelines in the future.
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