Finerenone Approved by FDA for Treatment of Adults With Heart Failure

The FDA has granted approval to a new indication of finerenone (Kerendia; Bayer Pharmaceuticals) for the treatment of adults with heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40% or more, such as mildly reduced LVEF (HFmrEF) or prescribed LVEF (HFpEF), according to a news release from Bayer.¹

"People with heart failure with left ventricular ejection fraction [of 40% or more] face the very real possibilities of hospitalization for heart failure of [cardiovascular] death due to their disease," said Alanna Morris-Simon, MD, MSc, senior medical director of US Medical Affairs at Bayer, in a news release. "Even with current treatments, 21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or cardiovascular 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."¹

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Finerenone Is Proven Effective in HF With LVEF of 40% or More

Finerenone is a non-steroidal mineralocorticoid receptor agonist that demonstrated significant efficacy in patients with HF in the randomized, double-blind, phase 3 FINEARTS-HF (NCT04435626) clinical trial. In that trial, which randomized patients to receive either finerenone or placebo, patients receiving finerenone experienced fewer total worsening HF events and deaths from cardiovascular causes compared with those receiving placebo.²

Importantly, rates of serious adverse events were comparable between the finerenone and placebo groups. With assessment taking place over 42 months, finerenone has demonstrated its significant long-term efficacy against preventing cardiovascular death in patients with HF.²

The new indication expands the current capabilities of finerenone. In 2021, finerenone gained its pivotal first FDA approval, being indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for HF in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). For these patients, finerenone has been widely recommended, including by the American Diabetes Association and the European Society of Cardiology.²

Now, patients with HF who may not present with T2D-associated CKD will have a new, effective treatment option for reducing their cardiovascular risk. Over 6 million US adults live with HF, and approximately 55% of these patients have an LVEF of 40% while presenting with multiple comorbidities. Reducing a patient's HF-related cardiovascular risk with finerenone could have the additional benefit of simultaneously improving other comorbid conditions.²

Based on the totality of evidence surrounding finerenone, the FDA recently accepted a supplemental new drug application and granted priority review to the medication, bolstering its path to this most recent approval.²

Future Considerations and Role of the Pharmacist

Finerenone has also been found to reduce the relative risk of cardiovascular events in patients with HF with improved ejection fraction (HFimpEF). According to a prespecified analysis of FINERTS-HF, investigators determined that patients with HFimpEF remain at heightened risk of adverse outcomes, but finerenone can effectively and safely mitigate this risk. It remains to be seen if finerenone's indication will eventually be expanded further to include patients in this population and others.³

"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, a professor of medicine at Harvard Medical School, director of the Clinical Trials Outcomes Center at Mass General Brigham, and chair of the executive committee for the FINEARTS-HF study, in a news release. "Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care."¹

Pharmacists are in a prime position to properly educate patients with HF on their potential for cardiovascular risk improvement with finerenone. Because it has already been approved and extensively marketed, patients will likely have some familiarity with the product, making the counseling process easier for pharmacists and providers. For patients who may be wary to receive the medication, pharmacists can assure them of the established safety and effectiveness of finerenone.

Furthermore, pharmacists should consistently monitor patients being administered finerenone for adverse events. In clinical trials, finerenone was associated with a heightened risk of hyperkalemia and a reduced risk of hypokalemia, which are key aspects that pharmacists and other providers should keep an eye out for during the administration process.⁴

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. McGovern G. FDA accepts priority review for finerenone new indication to include patients with heart failure. Pharmacy Times. Published March 17, 2025. Accessed July 10, 2025. https://www.pharmacytimes.com/view/fda-accepts-priority-review-for-finerenone-new-indication-to-include-patients-with-heart-failure

3. Pabon MA, Vardeny O, Vaduganathan M, et al. Finerenone in heart failure with improved ejection fraction: The FINEARTS-HF randomized clinical trial. JAMA Cardiology. 2025;10(7):740-745. doi:10.1001/jamacardio.2025.1101

4. Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2024;391(16):1475-1485. doi:10.1056/NEJMoa2407107