WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced today that FINEARTS-HF met its primary endpoint,1 achieving a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) heart failure (HF) events, defined as hospitalizations for HF or urgent HF visits. The randomized, double-blind, placebo-controlled, parallel-group, multi-center phase III cardiovascular outcomes study evaluated the efficacy and safety of KERENDIA® (finerenone) for investigational new use in patients with HF with a LVEF≥40%2 (left ventricular ejection fraction), a measurement that indicates how much blood the left ventricle of the heart pumps with each beat.4 In the FINEARTS-HF trial, no new safety signals were identified compared with those seen in previous studies with the compound.1
KERENDIA is approved to reduce the risk of cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with T2D.3
KERENDIA is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA) with established cardiovascular benefit (reduction in hospitalization for HF, CV death and non-fatal MI) in adults with CKD in T2D,3 and this new topline data provides positive results in a different patient population not limited to CKD in T2D— patients diagnosed with HF (LVEF>40).1
Bayer will present the FINEARTS-HF data at the European Society of Cardiology (ESC) Congress 2024 in September and plans to discuss submission for regulatory approval with the U.S. Food and Drug Administration (FDA).