The European Commission has approved the non-steroidal mineralocorticoid receptor antagonist (nsMRA) finerenone (Kerendia) for the treatment of adults with symptomatic chronic heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%.¹ The approval is based on positive results from the Phase III Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients With Heart Failure (FINEARTS-HF).²

Methodology

FINEARTS-HF was a randomised, double-blind, placebo-controlled trial that enrolled 6,001 adults with symptomatic HF (New York Heart Association [NYHA] class II–IV) and an LVEF of ≥40%.² Patients were assigned to receive either finerenone, titrated to a target dose of 20 mg or 40 mg once daily, or a matching placebo, in addition to standard therapy. The primary endpoint of the trial was a composite of cardiovascular (CV) death and total (first and recurrent) HF events, which were defined as hospitalisations for HF or urgent HF visits.¹

Results

The trial demonstrated that finerenone significantly reduced the composite primary endpoint of CV death and total HF events when compared with placebo.¹ A prespecified secondary analysis published in JAMA Cardiology assessed the performance of the biomarker-driven EMPEROR-Preserved prognostic model within the FINEARTS-HF cohort.² The model showed good discrimination for clinical outcomes. The relative treatment effect of finerenone on the composite of first HF hospitalisation or CV death was found to be consistent across all quintiles of baseline risk (P for interaction=.68). However, the analysis also revealed that the absolute risk reduction achieved with finerenone was substantially greater among patients who had a higher baseline risk score.²

In Practice

This approval introduces a new treatment option for patients with HF and LVEF ≥40%, a population with a high unmet medical need. According to the study’s Executive Committee Chair, Dr Scott D Solomon, "Finerenone addresses mineralocorticoid receptor overactivation, a key disease driver in heart failure, and based on its proven efficacy in the FINEARTS-HF trial can become a new pillar of comprehensive care to improve outcomes in this vulnerable population."¹ The secondary analysis further suggests that the EMPEROR-Preserved risk model "provided a practical framework for risk stratification and estimation of absolute treatment benefit" in this patient group.² This could aid clinicians in identifying higher-risk individuals who stand to gain the most significant absolute benefit from finerenone therapy.

This study was funded by Bayer AG.

References

1. Bayer. Kerendia™ approved in EU for new indication in adult patients with heart failure with LVEF ≥40%. 30 March 2026. https://www.bayer.com/media/en-us/kerendia-approved-in-eu-for-new-indication-in-adult-patients-with-heart-failure-with-lvef-40/

2. Chimura M, McDowell K, Jhund PS, et al. EMPEROR-Preserved Risk Model and Outcomes in the FINEARTS-HF Trial: A Prespecified Secondary Analysis of FINEARTS-HF. JAMA Cardiol. Published online March 28, 2026. https://doi.org/10.1001/jamacardio.2026.1049

Disclaimer

The information presented in this article is for educational purposes only. Any quotes included reflect the opinions of the individual quoted, and do not necessarily reflect the views of the publisher. The publisher does not guarantee the accuracy or completeness of the content and accepts no responsibility for any errors, or any consequences arising from its use.