FDA

Kerendia now approved for HF with preserved/mildly reduced EF

August 6, 2025

On July 14, 2025, FDA approved Kerendia (finerenone) to reduce the risk of CV death, hospitalization for heart failure (HF), and urgent HF visits in adults with HF with left ventricular ejection fraction (LVEF) ≥40%.

Efficacy

Approval was based on results from the phase 3 FINEARTS-HF trial (NCT04435626), which showed that, added to standard of care, Kerendia achieved a 16% relative risk reduction of the composite primary endpoint of CV death and total HF events, defined as hospitalization for HF or an urgent HF visit, compared with placebo added to standard of care (rate ratio, 0.84; 95% confidence interval, 0.74-0.95; p=0.007). Treatment effect was consistent across all prespecified subgroups including with or without SGLT2i use.

Safety

In the FINEARTS-HF trial, adverse reactions reported in ≥1% of patients on Kerendia and more frequently than placebo were hyperkalemia (9.7% vs. 4.2%), hypotension (7.6% vs. 4.7%), hyponatremia (1.9% vs. 0.9%), and events related to worsening renal function (18% vs. 12%).

Sources:

Kerendia (finerenone) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215341s009lbl.pdf Revised July 2025. Accessed August 5, 2025.

U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority Review. [News release]. 2025. https://www.bayer.com/en/us/news-stories/fda-approves-kerendia