FDA Approves Finerenone for Heart Failure With Left Ventricular Ejection Fraction

The FDA approved finerenone (Kerendia) to treat heart failure with left ventricular ejection fraction (LVEF) of 40% or greater. Finerenone is a nonsteroidal mineralocorticoid receptor agonist that blocks the overactivation of mineralocorticoid receptors in the heart and kidney.¹

The approval is based on the FINEARTS-HF (NCT04435626), showing that the drug achieved a 16% relative risk reduction of cardiovascular death and total heart failure events. | Image Credit: B-design - stock.adobe.com

“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,” Scott D. Solomon, MD, professor of Medicine at Harvard Medical School, said in a news release.¹ “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care.”

The approval was based on the FINEARTS-HF study (NCT04435626), showing that the drug achieved a 16% relative risk reduction of the composite primary end point of cardiovascular (CV) death and total heart failure events—including hospitalization for heart failure or an urgent heart failure visit—when compared to placebo.¹

In the study, investigators evaluated the effects of finerenone compared with the placebo in reducing CV deaths and total heart failure events. Data on the heart disease impact on patients' lives, change of kidney function, and how well finerenone treatment is tolerated. Patients included were aged 40 years and older who had heart failure with LVEF greater than or equal to 40%. The study was approximately 43 months long.²

The primary end point included the number of CV deaths and heart failure events, and the secondary end points included time to total heart failure events, improvement in NYHA class from baseline to month 12, change in total symptom score, time to first occurrence of composite renal end point, and time to death from any cause.²

After a median follow-up of 32 months, investigators reported 1083 primary-outcome events in 624 of 3003 patients in the finerenone group and 1283 in 719 of 2998 patients in the placebo group. For worsening heart failure, there were 842 events in the finerenone group and 1024 in the placebo group. The percentage of patient deaths from CV causes was 8.1% and 8.7%, respectively.³

Overall, the safety profile was consistent across all other studied indications. Finerenone was associated with more frequent hyperkalemia, hypotension, hyponatremia, and worsening renal function.¹

“People with heart failure with left ventricular ejection fraction ≥40% face the very real possibilities of hospitalization for heart failure or CV death due to their disease,” Alanna Morris-Simon, MD, MSc, senior medical director of US Medical Affairs at Bayer, said in the news release.¹ “Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or CV death, and 25% who experience hospitalization are readmitted due to heart failure within 1 year of discharge. Now, as a core pillar of treatment, Kerendia can help patients reduce these risks.”

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REFERENCES

1. US FDA approves Kerendia (finerenone) to treat patients with heart failure with left ventricular ejection fraction ≥ 40% following priority review. News release. Bayer. 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

2. Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone on Morbidity (Events Indicating Disease Worsening) & Mortality (Death Rate) in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF). ClinicalTrials.gov identification: NCT04435626. July 03, 2024. Accessed July 14, 2025. https://clinicaltrials.gov/study/NCT04435626

3. Solomon SD, McMurray JJV, Vaduganathan M, Claggett B, et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med. 2024;391:1475-1485. doi:10.1056/NEJMoa2407107