Bayer Finerenone approved in Japan for chronic heart failure

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%. 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%,” 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.”

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and a drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF with a left ventricular ejection fraction (LVEF) of ≥40% in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 95 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is also approved for the treatment of heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in the U.S.

In Japan, in the new joint 2025 Guidelines of the Japanese Circulation Society (JCS) and the Japanese Heart Failure Society (JHFS) on Diagnosis and Treatment of Heart Failure, finerenone is a MRA with a Class IIa recommendation for the treatment of HF with LVEF ≥ 40%. In this Guideline, finerenone also has Class I recommendation and Level A evidence for prevention of HF in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), based on the positive data on finerenone from the pivotal Phase III clinical studies FIDELIO-DKD and FIGARO-DKD in patients with CKD and T2D. The updated recommendation on prevention of HF in CKD associated with T2D is in line with the Guidelines of the European Society of Cardiology (ESC).

The approval of finerenone by the MHLW is based on the positive results from the Phase III FINEARTS-HF study, presented at ESC Congress 2024 and published in the New England Journal of Medicine. In FINEARTS-HF, finerenone achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits, versus placebo in addition to usual therapy. These benefits were demonstrated regardless of background therapy, comorbidities, or hospitalization status. The study is part of the ongoing MOONRAKER program, one of the largest Phase III clinical trial programs to date in heart failure, including over 15,000 patients, which aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.