Heart Failure Treatment: Finerenone’s Role in Patients with LVEF ≥40%

Bayer has announced that the U.S. Food and Drug Administration (FDA) has approved KERENDIA® (finerenone) for the treatment of adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, following a Priority Review of its supplemental New Drug Application (sNDA). This new indication positions finerenone as the only non-steroidal mineralocorticoid receptor antagonist (MRA) currently approved by the FDA for this patient group.

HF with LVEF ≥40%—encompassing mildly reduced (HFmrEF) and preserved ejection fraction (HFpEF)—affects approximately 3.7 million adults in the U.S. Despite existing guideline-directed medical therapy, these patients continue to face a high risk of hospitalization for HF and cardiovascular (CV) death. Each hospitalization is associated with more than double the risk of subsequent CV mortality, underlining the ongoing burden of disease.

The approval is based on data from the Phase III FINEARTS-HF trial. This randomized, double-blind, placebo-controlled study evaluated finerenone in over 6,000 patients with symptomatic HF (NYHA class II–IV) and LVEF ≥40%, who were already on diuretics. Over a median follow-up of up to 42 months, finerenone, added to standard-of-care therapies, achieved a 16% relative risk reduction in the composite endpoint of CV death and total HF events (defined as hospitalizations or urgent HF visits) versus placebo (RR=0.84, 95% CI: 0.74-0.95, p=0.007). The benefit was consistent across prespecified subgroups, including patients receiving SGLT2 inhibitors.

As a selective, non-steroidal MRA, finerenone blocks overactivation of the mineralocorticoid receptor in the heart and kidneys, addressing pathophysiology distinct from that of existing therapies. Its overall safety profile in this population was similar to that observed in previous indications. In FINEARTS-HF, adverse events reported more frequently with finerenone than placebo included hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), hyponatremia (1.9% vs 0.9%), and worsening renal function (18% vs 12%).

This approval extends KERENDIA’s cardiovascular benefits beyond its established indication in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), where it has been approved since 2021 to reduce the risk of CV death, HF hospitalization, sustained eGFR decline, end-stage kidney disease, and non-fatal myocardial infarction.

KERENDIA’s broader clinical program includes the MOONRAKER initiative—expected to be among the largest HF research efforts to date—which, along with the FINEARTS-HF trial, aims to build extensive evidence for the role of finerenone across diverse HF populations. This complements the ongoing THUNDERBALL program evaluating finerenone in CKD, which includes studies such as FIDELIO-DKD and FIGARO-DKD.

The expanded approval of finerenone for HF with LVEF ≥40% underscores an important advancement for a substantial patient group that remains at considerable risk despite contemporary therapy. With this new indication, finerenone is positioned as a key option to help reduce CV events and hospitalizations in a population with limited alternatives.