FDA Accepts Finerenone sNDA for Heart Failure, Grants Priority Review

The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for finerenone (KERENDIA) for heart failure (HF), granting the non-steroidal mineralocorticoid receptor antagonist (nsMRA) Priority Review designation.1

Announced by Bayer on March 17, 2025, finerenone’s sNDA is targeting the treatment of adult patients with HF with a left ventricular ejection fraction (LVEF) of ≥40%, including heart failure with mildly-reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

“[Finerenone] is already an established pillar of therapy to improve cardiovascular outcomes for patients with type 2 diabetes (T2D) and chronic kidney disease, and Bayer is committed to investigating [finereone’s] benefits in other patient populations, including HF,” said Alanna Morris-Simon, MD, MSc, senior medical director of US medical affairs at Bayer.1

Priority Review is awarded for medicines that could offer a notable benefit on the safety or efficacy of the prevention, diagnosis, or treatment of a particular condition. In July 2021, the FDA initially approved finerone to reduce the risk of sustained estimated glomerular filtrate rate (eGFR) decline, end-stage kidney disease, cardiovascular (CV) death, non-fatal myocardial infarction (MI), and hospitalization for HF in adults with CKD and T2D.2

Current submission of the finerenone sNDA was based on positive data from the randomized double-blind, placebo-controlled Phase 3 FINEARTS-HF trial investigating the efficacy and safety of finerenone for reducing CV death and HF events in nearly 6,000 patients. In the trial, finerenone achieved a statistically significant 16% reduction in the composite of CV death and total HF events, compared with placebo (rate ratio, 0.84; 95% CI, 0.74–0.95; P = .007).1

Safety data showed serious adverse events comparable between treatment groups, with events identified in 38.7% of the finerenone group and 40.5% of the placebo group. Discontinuation of the trial drug for a cause other than death was additionally similar between groups, at 20.4% and 20.6% respectively.

“I think, traditionally, HFpEF has been viewed as a chronic disease with slower disease progression, perhaps low clinical event rates and low mortality rates,” Muthiah Vaduganathan, MD, MPH, center for cardiometabolic implementation science at Brigham and Women's Hospital and a member of the FINEARTS-HF investigative team, told HCPLive.3 “But what we're recognizing is that many phenotypes of HFpEF do progress rapidly, and so upfront initiation of therapies to attenuate that risk of disease progression is of high importance.”

The trial-HF is part of Bayer’s MOONRAKER program for finerenone, expected to be one of the largest HF study programs with more than 15,000 patients in total. Approximately 6.7 million adults in the US experience HF, of whom more than half (55%) report an LVEF ≥40%. These populations experience multiple comorbidities, including obesity, diabetes, hypertension, and CKD, with high rates of hospitalization and mortality.4

“In fact, a 2024 report on heart failure trends and outcomes published in the Journal of Cardiac Failure showed that in patients with HFpEF, 5-year mortality was 75.7%,” said Robert Perkins, MD, MPH, vice president of US Medical Affairs at Bayer.1 “The FDA’s decision to grant Priority Review designation to our application underlines the significant unmet need these patients face.”

References

1. Bayer. U.S. FDA accepts Supplemental New Drug Application Under Priority Review for new indication for kerendia® (finerenone) in patients with heart failure. U.S. FDA Accepts Supplemental New Drug Application Under Priority Review for New Indication for KERENDIA® (finerenone) in Patients with Heart Failure | Bayer United States. March 17, 2025. Accessed March 17, 2025. https://www.bayer.com/en/us/news-stories/kerendiar-finerenone-in-patients-with-heart-failure.

2. Campbell P. Finerenone (Kerendia) approved for chronic kidney disease associated with type 2 diabetes. HCP Live. May 19, 2023. Accessed March 17, 2025. https://www.hcplive.com/view/finerenone-kerendia-approved-chronic-kidney-disease-associated-with-type-2-diabetes.

3. A pillared approach: A suite of therapies for a spectrum of metabolic disease. HCP Live. December 5, 2025. Accessed March 17, 2025. https://www.hcplive.com/view/a-pillared-approach-a-suite-of-therapies-for-a-spectrum-of-disease.

4. Golla MSG, Hajouli S, Ludhwani D. Heart Failure and Ejection Fraction. [Updated 2024 May 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK553115/