Bayer 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 with Left Ventricular Ejection Fraction (LVEF) of ≥40 percent, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

“The approval of Finerenone in Japan helps to address a major gap in heart failure care: the high rates of cardiovascular events such as hospitalisation for heart failure or cardiovascular death in the large and growing group of patients with heart failure with left ventricular ejection fraction of ≥40 percent. 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,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialisation and Member, Pharmaceuticals Leadership Team, Bayer.

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the Mineralocorticoid Receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with heart failure with a LVEF of ≥40 percent in the phase III study FINEARTS-HF.

It 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 II diabetes in over 95 countries worldwide, including in China, Europe, Japan and the US.

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 the only MRA with a Class IIa recommendation for the treatment of HF with LVEF ≥ 40 percent. In this Guideline, Finerenone also has Class I recommendation and Level A evidence for prevention of HF in patients with type II diabetes and CKD, based on the positive data on Finerenone from the phase III clinical studies FIDELIO-DKD and FIGARO-DKD in patients with CKD and type II diabetes. The updated recommendation on prevention of heart failure in CKD associated with type II diabetes 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 reduction of cardiovascular death and total (first and recurrent) heart failure events, defined as hospitalisations for heart failure or urgent heart failure visits, versus placebo, in addition to usual therapy. These benefits were demonstrated regardless of background therapy, comorbidities, or hospitalisation status. The study is part of the ongoing MOONRAKER programme, one of the largest phase III clinical trial programmes to date in heart failure, including more than 15,000 patients, which aims to establish an understanding of Finerenone in heart failure across a broad spectrum of patients and clinical settings.