FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More

The US Food and Drug Administration (FDA) has approved finerenone (Kerendia) for adults with heart failure with a left ventricular ejection fraction (LVEF) of 40% or greater.1

Announced by Bayer on July 14, 2025, the approval indicates finerenone for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). The approval, which was supported by data from the FINEARTS-HF trial, comes just more than 4 years after the FDA approved Bayer’s non-steroidal mineralocorticoid receptor agonist (nsMRA) for treatment of patients with chronic kidney disease associated with type 2 diabetes.2

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – a large and growing group of patients with a poor prognosis,” said Scott D. Solomon, MD, Professor of Medicine, Harvard Medical School, Director, Clinical Trials Outcomes Center, Mass General Brigham, and Chair of the Executive Committee for the FINEARTS-HF study.1 “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”

After a decade marked with advancement concentrated in heart failure with reduced ejection fraction, clinical trial data from finerenone, along with the major trials in incretin therapies, have signaled the age of a new era for management of patient populations with ejection fractions 40% or greater, with this latest approval positioning finerenone as a second pillar of therapy among these patients alongside SGLT2 inhibitors.1,2

The FINEARTS-HF trial used in support of the application was a phase 3, international, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of finerenone in patients with heart failure. Bayer announced topline results from the trial in August 2024 and presented at the European Society of Cardiology (ESC) Congress 2024 less than a month later.1,2,3

The trial enrolled 6016 patients with New York Heart Association class II to IV heart failure, LVEF of 40% or greater, and ongoing diuretic therapy for at least 30 days prior to randomization. Participants were randomized 1:1 to receive either finerenone or placebo and followed for up to 42 months. The primary composite endpoint was cardiovascular death or total heart failure events, defined as hospitalizations or urgent visits for heart failure.3

After excluding 13 patients from a single site due to major protocol violations and 1 patient with duplicate randomization, 3003 patients were assigned to finerenone and 2998 to placebo. Baseline characteristics were well balanced between groups and the mean LVEF was 53% (SD, 8), with 69.1% of patients were classified as NYHA class II. Concomitant therapies at baseline among the cohort included β-blockers (84.9%), angiotensin-converting enzyme inhibitors (35.9%), angiotensin receptor blockers (35.0%), angiotensin receptor–neprilysin inhibitors (8.5%), and sodium-glucose cotransporter 2 inhibitors (13.6%).3

Finerenone significantly reduced the incidence of the primary endpoint, with a 16% relative risk reduction compared with placebo (rate ratio [RR], 0.84; 95% CI, 0.74-0.95; P = .007). A total of 1083 primary endpoint events occurred in 624 patients in the finerenone group compared with 1283 events in 719 patients in the placebo group.3

Data presented at ESC Congress 2024 suggested finerenone reduced heart failure hospitalizations by 18% (RR, 0.82; 95% CI, 0.71-0.94; P = .006). The relative risk reduction in cardiovascular death was 7% but was not statistically significant (hazard ratio [HR], 0.93; 95% CI, 0.78-1.11). No significant differences were observed between groups for all-cause mortality (HR, 0.93; 95% CI, 0.83-1.06) or composite kidney outcomes (HR, 1.33; 95% CI, 0.94-1.89). Additional trial analyses have offered evidence suggesting the effects of finerenone on cardiovascular death and worsening heart failure events were present regardless of ejection fraction, frailty, and age in FINEARTS-HF.3,4,5

“People with heart failure with left ventricular ejection fraction ≥40% face the very real possibilities of hospitalization for heart failure or [cardiovascular] death due to their disease,” said Alanna Morris-Simon, MD, MSc, senior medical director of US Medical Affairs at Bayer.1 “Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or [cardiovascular] death, and25% who experience hospitalization are readmitted due to heart failure within one year of discharge. Now, as a core pillar of treatment, KERENDIA can help patients reduce these risks.”

The MOONRAKER program is Bayer’s global heart failure research initiative evaluating finerenone in over 15,000 patients across four phase 3 trials. It spans heart failure with preserved, mildly reduced, and reduced ejection fraction, including recently hospitalized patients and those ineligible for steroidal MRAs. The goal is to establish finerenone’s safety and efficacy across a broad spectrum of heart failure populations beyond diabetic kidney disease.1,2

“There's so, so little therapeutic options available. So, having a second pillar as part of HFpEF management beyond SGLT2s is great and one that's better tolerated than spironolactone,” explained Marat Fudim, MD, MD, MHS, advanced heart failure specialist and associate professor at Duke University Medical Center, in an interview with HCPLive. “MRAs are great. I love them. I prescribe them to every HFpEF patient, but that's the firstst to come off, because it has quite a bit of a side effect profile. So, solely on the fact that it has a better side effect profile and also has more definitive data. It's just going to be a much more exciting therapy option.”

References:

Bayer. U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review. Bayer. Published July 14, 2025. Accessed July 14, 2025. https://bayer2019tf.q4web.com/news/news-details/2025/U-S--FDA-Approves-KERENDIA-finerenone-to-Treat-Patients-With-Heart-Failure-With-Left-Ventricular-Ejection-Fraction-40-Following-Priority-Review/default.aspx

Connor Iapoce. FDA Accepts Finerenone sNDA for Heart Failure, Grants Priority Review. HCP Live. Published March 17, 2025. Accessed July 14, 2025. https://www.hcplive.com/view/fda-accepts-finerenone-snda-for-heart-failure-grants-priority-review

Solomon SD, John J.V. McMurray, Muthiah Vaduganathan, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. New England Journal of Medicine. 2024;391(16). doi: 10.1056/nejmoa2407107

Docherty KF, Henderson AD, Jhund PS, et al. Efficacy and Safety of Finerenone Across the Ejection Fraction Spectrum in Heart Failure with Mildly Reduced and Preserved Ejection Fraction: a Prespecified Analysis of The FINEARTS-HF Trial. Circulation. Published online September 29, 2024. doi: 10.1161/circulationaha.124.072011

Misato Chimura, Petrie MC, Schou M, et al. Finerenone Improves Outcomes in Patients with Heart Failure with Mildly Reduced or Preserved Ejection Fraction Irrespective of Age: A Prespecified Analysis of FINEARTS-HF. Circulation Heart Failure. 2024;17(11). doi: 10.1161/circheartfailure.124.012437