Finerenone's FDA Approval Marks a Turning Point in HFpEF Management

The July 2025 approval of finerenone (Kerendia) by the US Food and Drug Administration (FDA) for the management of heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) could serve as a watershed moment for cardiology in the coming years.

Buoyed by results from the phase 3 FINEARTS-HF trial, the therapy, a first-in-class nonsteroidal mineralocorticoid receptor antagonist (nsMRA), stands poised to become a pillar of therapy for this patient population.

In part 2 of this 4-part HCPLive RX Review, leading subject matter experts Stephen Greene, MD, Andrew Sauer, MD, and Muthiah Vaduganathan, MD, MPH, reflect on the recent FDA approval of finerenone.

A key point of the discussion highlighted by Sauer was the broad applicability of finerenone. The pivotal FINEARTS-HF trial enrolled over 6,000 patients across 37 countries, and the benefits were consistent across subgroups, reinforcing the idea that this is not a niche therapy but rather one with wide clinical utility.

The panelists also addressed the timing of benefit. Vaduganathan points out that, contrary to assumptions MRAs act only through long-term structural effects, early improvements were observed within 28 days of initiation—both in clinical endpoints and in patient-reported quality of life. These early signals strengthen the case for prompt therapy initiation, even in acute or recently hospitalized patients.

The panel shines light on ongoing trials like REDEFINE-HF and CONFIRMATION-HF, which they believe will further clarify implementation pathways in real-world settings. Overall, the discussion underscored a paradigm shift: HFpEF is now a condition with clearly actionable therapies, and clinicians have growing tools to improve outcomes with timely, multi-mechanism treatment strategies.

Panelists:

Stephen Greene, MD, is an advanced heart failure specialist and an associate professor in the Division of Cardiology at Duke Clinical Research Institute. Greene serves as moderator for this discussion.

Muthiah Vaduganathan, MD, MPH, is a cardiologist and the codirector of the Center for Cardiometabolic Implementation Science at Brigham and Women's Hospital. Vaduganathan also served as an investigator on the pivotal FINEARTS-HF trial.

Andrew Sauer, MD, is a cardiologist and the codirector of Cardiovascular Research as well as the executive director of the Cardiometabolic Center Alliance at Saint Luke's Health System.

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Relevant disclosures for Greene include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others. Relevant disclosures for Vaduganathan include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for Sauer include Boston Scientific, Medtronic, Abbott, Impulse Dynamics, Amgen Inc., Biotronik, General Prognostics, Acorai, Bayer Healthcare Pharmaceuticals, CSL Vifor, and others.

References:

1. 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

2. 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