Bayer’s Finerenone Approved in Japan for Chronic Heart Failure Treatment
Bayer received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for finerenone (Kerendia), a non-steroidal selective mineralocorticoid receptor antagonist (nsMRA), to treat adult patients with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, including HFmrEF and HFpEF.1
The approval addresses high rates of cardiovascular events like HF hospitalization or CV death in Japan's aging population, where ~1.2 million have HF and ~60% have LVEF ≥40%.1
Based on Phase III FINEARTS-HF trial results (presented ESC 2024, published NEJM), finerenone reduced composite of CV death and total HF events vs. placebo, added to standard therapy.1
In Japan's 2025 JCS/JHFS Guidelines, finerenone has Class IIa recommendation for HF with LVEF ≥40%; Class I, Level A for preventing HF in T2D+CKD patients.1
Finerenone previously approved in Japan for T2D+CKD but not yet reimbursed for HF alone; this expands its role in cardio-renal-metabolic syndrome.14
Sources:
1. https://medicaldialogues.in/news/industry/pharma/bayer-finerenone-approved-in-japan-for-chronic-heart-failure-161161