FDA Approves Finerenone for Treatment of Heart Failure With LVEF ≥40%: Daily Dose

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On July 14, 2025, we reported on the US FDA approval of finerenone (KERENDIA®, Bayer) for the treatment of adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%.

The approval

Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (nsMRA) that is indicated for 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. The expanded indication makes finerenone the only MRA approved for HF with mildly reduced or preserved ejection fraction.

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.

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