WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today 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%.
The submission is based on positive results from the Phase III FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% in patients with HF and a LVEF of ≥40% compared to placebo in addition to a patients’ prescribed treatment regimen. Serious adverse events were comparable between treatment groups, occurring in 38.7% (1,157/2,993) of the finerenone group and 40.5% (1,213/2,993) of the placebo group.1 The results were presented at the 2024 European Society of Cardiology (ESC) Congress and published 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%).