Bayer’s Kerendia Gets FDA Priority Review for Heart Failure with Preserved Ejection Fraction

German pharmaceutical giant Bayer (ETR: BAYN) announced that a supplementary New Drug Application (sNDA) for its Kerendia (finerenone), a mineralocorticoid receptor (MR) antagonist, has been accepted for review by the US Food and Drug Administration (FDA) with priority review status. The targeted indication is adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, including mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

Clinical Significance
Finerenone, approved in over 90 countries and regions for chronic kidney disease (CKD) associated with type 2 diabetes (T2D), is the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF and an LVEF of ≥40%. The Phase III study FINEARTS-HF provided robust evidence supporting its efficacy and safety in this patient population.-Fineline Info & Tech