The U.S. FDA has approved KERENDIA® (finerenone), a non-steroidal mineralocorticoid receptor antagonist (nsMRA), for treating adults with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40%. This approval follows a Priority Review and is based on findings from the Phase III FINEARTS-HF trial. The new indication allows KERENDIA to be used for reducing cardiovascular (CV) death, hospitalization for heart failure, and urgent heart failure visits in patients with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF).
The FINEARTS-HF trial enrolled over 6,000 symptomatic heart failure patients (NYHA class II–IV) with LVEF ≥40%, randomized to receive finerenone or placebo. Over a follow-up of up to 42 months, finerenone showed a 16% relative risk reduction in the composite primary endpoint of CV death or total HF events compared to placebo (RR 0.84, 95% CI: 0.74–0.95; p=0.007). Heart failure hospitalizations were also reduced by 18%, although reduction in CV death (7%) was not statistically significant.
The safety profile of KERENDIA remained consistent with earlier trials, with the most common adverse effects including hyperkalemia (9.7% vs 4.2% with placebo), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%). Events of worsening renal function occurred more often in the treatment group (18% vs 12%).
KERENDIA’s expanded role marks a pivotal shift in HFpEF management, positioning it as a second therapeutic pillar alongside SGLT2 inhibitors. Experts, including Dr. Scott Solomon and Dr. Marat Fudim, emphasized its potential due to better tolerability compared to steroidal MRAs and its efficacy across diverse HF patient subgroups.
This approval is part of Bayer’s larger MOONRAKER program, which includes more than 15,000 patients across four ongoing Phase III trials aimed at evaluating finerenone in varying HF conditions. Since 2021, KERENDIA has been approved for reducing cardiovascular and renal risks in adults with CKD associated with type 2 diabetes.
Now, with this expanded label, KERENDIA addresses an estimated 3.7 million U.S. adults with HF and LVEF ≥40%, providing an evidence-based option to reduce the high risk of hospitalizations and mortality in this underserved patient population. Detailed FINEARTS-HF results were also published in the New England Journal of Medicine.
Source: https://www.bayer.com/en/us/news-stories/fda-approves-kerendia
