KERENDIA (finerenone) was approved by the Food and Drug Administration (FDA) for heart failure with a left ventricular ejection fraction (LVEF) of 40% or higher. The agency granted Priority Review of the supplemental New Drug Application (sNDA) by confirming the cardiovascular safety outcomes.
Around 3.7 million adults in the U.S. have heart failure (HF) and left ventricular ejection fraction (LVEF) ≥ 40%, known as HFmrEF or HFpEF. Patients with HFmrEF and HFpEF continue to have a high risk for hospitalization and increased mortality, despite standard therapy options. This creates an increased burden on the healthcare system. The risk of cardiovascular (CV) death among adult patients increases twofold with each hospitalization.
The approval was based on the results derived from the Phase III FINEARTS HF trial, which revealed that KERENDIA when added to standard care was associated with a 16% lower relative risk of the composite primary endpoint of cardiovascular death and total heart failure events (including hospitalization or urgent visit for heart failure) compared to placebo, with the results being significant (RR = 0.84; 95% CI: 0.74 to 0.95; p = 0.007). The treatment effect was also similar across all prespecified subgroups, including those with or without SGLT2i use.
KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that targets HF with LVEF 40% to specifically and robustly inhibit the overactivation of mineralocorticoid receptors in the heart and kidneys. KERENDIA addresses HF with LVEF above 40% through a different pathway.
It maintained a consistent safety profile, and in FINEARTS-HF, the adverse events were reported renal function decline (18% compared to 12% with placebo), hyponatremia (1.9% compared to 0.9% placebo), hypotension (7.6% compared to 4.7% placebo), and hyperkalemia (9.7% compared to 4.2% placebo).
Scott D. Solomon, MD, Professor of Medicine at Harvard Medical School, stated that FDA approval of finerenone provides a significant option for patients with heart failure with LVEF of 40% or more, and that it could play an important role in care based on strong clinical evidence.
Alanna Morris Simon, MD, MSc, Senior Medical Director, U.S. Medical Affairs at Bayer, reported that patients with heart failure and a left ventricular ejection fraction (LVEF) of 40% or greater have an extremely high risk for hospitalization and cardiovascular death, especially when looking at patients suffering from heart failure with reduced ejection fraction. Despite current treatments, about 21% of symptomatic heart failure patients are hospitalized or die from cardiovascular causes, and 25% of those previously hospitalized are readmitted within a year. KERENDIA has the potential to help lower these risks as part of heart failure management.
KERENDIA is approved for managing chronic kidney disease in adults with type 2 diabetes, aiming to reduce the incidence of cardiovascular death, heart failure-related hospital admissions, non-fatal myocardial infarction (MI), sustained reductions in estimated glomerular filtration rate (GFR), and progression to end-stage renal disease (ESRD). With this new indication, KERENDIA has extended its known cardiovascular indication in a broadening patient population of both CKD due to T2D-adult patients as well as HF with LVEF ≥ 40%.
The FINEARTS HF trial was a Phase III, randomized, double-blind, placebo-controlled study involving approximately 6,000 patients with symptomatic heart failure (NYHA class II to IV) and an LVEF of≥40% (12 months). All patients were taking diuretics for at least 30 days prior to study entry and throughout the study period. They were randomized to receive daily treatment with either KERENDIA or placebo, in addition to standard care, for a maximum of 42 months. The primary endpoint combined cardiovascular death with all heart failure events, including hospital admissions and urgent care visits. FINEARTS HF is part of the global MOONRAKER program, which has more than 15,000 patients enrolled.
References: BAYER. U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review. Published July 14, 2025. Accessed July 15, 2025 Bayer United States of America – U.S. FDA Approves KERENDIA® (finerenone) to Treat Patients With Heart Failure With Left Ventricular Ejection Fraction ≥40% Following Priority Review
