Bayer announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for KERENDIA® (finerenone) for the treatment of patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%.

This submission is based on the positive results from the Phase III FINEARTS-HF trial, which demonstrated that finerenone achieved a statistically significant reduction in the composite of cardiovascular death and total HF events (including unplanned hospitalization or urgent HF visits) by 16% in patients with HF and a LVEF of ≥40%, compared to placebo in addition to patients’ prescribed treatment regimen. Results from the trial were presented at the European Society of Cardiology (ESC) Congress 2024 and published simultaneously in The New England Journal of Medicine.

KERENDIA is the first non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) to meet a primary cardiovascular endpoint in a Phase III study investigating patients with HF with mildly reduced or preserved ejection fraction (LVEF ≥40%).

Dr. Alanna Morris, Senior Medical Director of U.S. Medical Affairs at Bayer, stated, “More than half of the approximately 6.7 million adults in the U.S. diagnosed with heart failure have an LVEF ≥40%, but there are limited guideline-directed treatment options available for these patients. If approved, KERENDIA could serve as a new pillar of therapy in this disease and improve cardiovascular outcomes for patients with high unmet medical need.”

KERENDIA is already approved for the treatment of adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), reducing the risk of cardiovascular death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained eGFR decline, and end-stage kidney disease. The results from the FINEARTS-HF trial expand the potential benefits of KERENDIA to a broader patient population, including those diagnosed with HF with LVEF ≥40%, irrespective of CKD or T2D.