Bayer Submits Supplemental New Drug Application to U.S. FDA Seeking New Indication for KERENDIA® (finerenone) in Patients with Heart Failure with Left Ventricular Ejection Fraction of ≥40%

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 t