Bayer reports positive data from phase III FINEARTS-HF study of finerenone in patients with heart failure and LVEF at ESC Congress 2024

The Phase III FINEARTS-HF study revealed that finerenone (Kerendia/Firialta) significantly improved cardiovascular outcomes in heart failure (HF) patients with a left ventricular ejection fraction (LVEF) ≥40%. Finerenone reduced the risk of cardiovascular death and total HF events by 16% compared to placebo, over a median of 32 months (RR 0.84 [95% CI, 0.74-0.95; p=0.0072]). It also reduced secondary endpoints of HF events and improved health status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) (difference of 1.6 points [95% CI, 0.8-2.3; p<0.0001]).

The study involved around 6,000 patients across 37 countries. Finerenone was well-tolerated, though hyperkalemia-related adverse events were more common. Bayer plans to seek marketing approval for finerenone for HF with LVEF ≥40%. The FINEARTS-HF results were presented at ESC Congress 2024 and published in the New England Journal of Medicine.