WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer announced today that the U.S. Food and Drug Administration (FDA) accepted its supplemental new drug application (sNDA) and granted Priority Review designation for KERENDIA^® (finerenone) for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e., mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.4

Approximately 6.7 million adults in the U.S. live with HF,2 a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood.7 Of these patients, about 55% have a LVEF ≥40%.2 Most are balancing multiple comorbidities, such as obesity, diabetes, hypertension and chronic kidney disease (CKD).7

“People with heart failure with mildly reduced or preserved ejection fraction face substantial challenges in diagnosis, treatment and follow-up care,” said Robert Perkins, M.D., MPH, FACP, Vice President, US Medical Affairs, Bayer. “In fact, a 2024 report on heart failure trends and outcomes published in the Journal of Cardiac Failure showed that in patients with heart failure with preserved ejection fraction, 5-year mortality was 75.7%.8 The FDA’s decision to grant Priority Review designation to our application underlines the significant unmet need these patients face.”