Berlin, December 22, 2025 – Bayer today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of adult patients with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) of 40% and higher, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).
Heart failure is a rapidly growing public health issue, affecting over 64 million people worldwide. It also is a growing burden in Japan’s aging society. An estimated 1.2 million people are living with HF nationwide, and about six in ten have LVEF 40% and higher. These patients frequently have multiple comorbidities such as hypertension and atrial fibrillation, contributing to hospitalizations and mortality.
“The approval of finerenone in Japan helps to address a major gap in heart failure care: the high rates of cardiovascular events such as hospitalization for heart failure or cardiovascular death in the large and growing group of patients with heart failure with left ventricular ejection fraction of 40% and higher,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “In the FINEARTS-HF study, finerenone showed early, consistent and sustained efficacy across a range of patient profiles and in addition to existing treatments. We are enthusiastic about the potential of finerenone to emerge as a foundational therapy addressing the substantial needs of these patients in Japan.”
https://www.bayer.com/media/en-us/...ents-with-chronic-heart-failure/
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