FDA Approves Finerenone for Heart Failure With LVEF ≥40% Following Positive Phase 3 Data

The US Food and Drug Administration (FDA) has approved finerenone (KERENDIA®, Bayer), a nonsteroidal mineralocorticoid receptor antagonist (nsMRA), for the treatment of adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, Bayer announced. This decision follows a Priority Review of Bayer’s supplemental New Drug Application and marks the first approval of an MRA for this HF population.

The expanded indication makes finerenone the only MRA approved for HF with mildly reduced or preserved ejection fraction (HFmrEF or HFpEF), a group that includes approximately 3.7 million adults in the US. Despite standard care, patients in this group face high risks of hospitalization for HF and cardiovascular (CV) death.

The approval is supported by results from the FINEARTS-HF Phase 3 trial, which evaluated finerenone on top of standard HF therapy in patients with LVEF ≥40%. The study enrolled approximately 6000 participants and assessed the composite outcome of CV death and total HF events (hospitalizations or urgent visits).

• Finerenone demonstrated a 16% relative risk reduction in the composite endpoint compared with placebo (RR = 0.84; 95% CI, 0.74–0.95; P = .007).
• The treatment effect was consistent across all prespecified subgroups, including those taking or not taking SGLT2 inhibitors.

Published in the New England Journal of Medicine, the FINEARTS-HF trial also found that finerenone maintained a safety profile similar to previous studies. Adverse events reported in ≥1% of participants and more frequent with finerenone vs placebo included:

• Hyperkalemia (9.7% vs 4.2%)
• Hypotension (7.6% vs 4.7%)
• Hyponatremia (1.9% vs 0.9%)
• Worsening renal function events (18% vs 12%)

“Finerenone can become a new pillar of comprehensive care for patients with heart failure and LVEF ≥40%,” Scott D. Solomon, MD, Chair of the FINEARTS-HF Executive Committee and professor of medicine at Harvard Medical School, said in the press release.

The new indication adds to finerenone’s previously approved use in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) to reduce the risk of CV death, HF hospitalization, nonfatal MI, eGFR decline, and end-stage kidney disease.

“This approval is especially meaningful given the persistent risk of hospitalization or CV death in this patient population, even with guideline-directed therapy,” Alanna Morris-Simon, MD, MSc, Senior Medical Director at Bayer US Medical Affairs, said in a press release.

FINEARTS-HF is part of Bayer’s ongoing MOONRAKER clinical program, which includes more than 15 000 participants globally and aims to provide comprehensive evidence on finerenone across a wide range of HF patient populations and care settings.