WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer today announced that the U.S. Food and Drug Administration (FDA) approved KERENDIA® (finerenone) to treat patients with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%,¹ following the agency’s Priority Review of its supplemental New Drug Application (sNDA).

Even with guideline-directed medical treatment, the approximately 3.7 million adults in the U.S. with HF with LVEF ≥40%, also known as mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF), face high rates of hospitalization for HF, impacting survival and placing considerable strain on healthcare systems.² Each hospitalization is associated with a more than two-fold increase in patients’ risk of cardiovascular (CV) death.³

The approval was based on results from the Phase III FINEARTS-HF trial, which showed that, on top of standard of care, KERENDIA achieved a 16% relative risk reduction of the composite primary endpoint of CV death and total HF events, defined as hospitalization for HF or an urgent HF visit, compared to placebo on top of standard of care (RR=0.84, 95% CI: 0.74-0.95, p=0.007). ¹ The treatment effect was consistent across all prespecified subgroups including with or without SGLT2i use.¹