Bayer's Finerenone Gains Regulatory Momentum for Heart Failure Treatment Across Global Markets
Key Insights
Japan's Ministry of Health, Labour and Welfare approved finerenone (Kerendia) for treating chronic heart failure patients with left ventricular ejection fraction ≥40%, addressing a significant unmet medical need.
The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending finerenone for the same indication in the EU, with final approval expected within weeks.
The approvals are based on the pivotal Phase III FINEARTS-HF study, which demonstrated statistically significant reduction in cardiovascular death and heart failure events across approximately 6,000 patients.
Bayer's finerenone (Kerendia) has achieved significant regulatory milestones for heart failure treatment, with Japan's Ministry of Health, Labour and Welfare (MHLW) granting approval on December 22, 2025, and the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion on January 30, 2026, for treating adult patients with chronic heart failure with left ventricular ejection fraction (LVEF) ≥40%.
Addressing Critical Unmet Medical Need
Heart failure affects over 64 million people worldwide, with approximately half suffering from LVEF ≥40%, including both mildly reduced LVEF (HFmrEF) and preserved LVEF (HFpEF). In Japan alone, an estimated 1.2 million people live with heart failure, with about six in ten having LVEF ≥40%. These patients frequently present with 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 at Bayer.
In Europe, at least 15 million people suffer from heart failure, with repeated hospitalizations contributing to an estimated 29 billion Euros in annual heart failure-related costs across the EU. Time trends suggest that patients with LVEF ≥40% will soon account for the majority of those hospitalized with heart failure, yet they currently have limited approved and guideline-directed therapy options.
Breakthrough Mechanism of Action
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and represents the first drug targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in patients with heart failure and LVEF ≥40%. The drug blocks harmful effects of mineralocorticoid receptor overactivation, which contributes to chronic kidney disease progression and cardiovascular damage through metabolic, hemodynamic, inflammatory, and fibrotic factors.
Pivotal Clinical Evidence
The regulatory approvals are based on positive results from the Phase III FINEARTS-HF study, a randomized, double-blind, placebo-controlled, multicenter trial that enrolled approximately 6,000 patients from more than 630 sites across 37 countries. The study investigated finerenone's efficacy and safety for preventing cardiovascular death and heart failure events in patients with symptomatic heart failure (New York Heart Association class II-IV) with LVEF ≥40%.
The primary endpoint was a composite of cardiovascular death and total (first and recurrent) heart failure events, defined as hospitalizations for heart failure or urgent heart failure visits. Finerenone achieved a statistically significant and clinically meaningful reduction of this composite endpoint versus placebo when added to usual therapy. Importantly, these benefits were demonstrated regardless of background therapy, comorbidities, or hospitalization status, including patient subgroups based on ejection fraction or baseline use of SGLT2 inhibitors.
Guideline Recognition and Clinical Impact
In Japan, the new joint 2025 Guidelines of the Japanese Circulation Society and the Japanese Heart Failure Society on Diagnosis and Treatment of Heart Failure recognize finerenone as the only mineralocorticoid receptor antagonist with a Class IIa recommendation for treating heart failure with LVEF ≥40%. The drug also received a Class I recommendation with Level A evidence for preventing heart failure in patients with type 2 diabetes and chronic kidney disease.
Comprehensive Development Program
FINEARTS-HF is part of the ongoing MOONRAKER program, one of the largest Phase III clinical trial programs in heart failure to date, including over 15,000 patients. This comprehensive program aims to establish understanding of finerenone across a broad spectrum of patients and clinical settings. The broader FINEOVATE clinical study program comprises ten Phase III studies with dedicated programs in both heart failure and chronic kidney disease.
Global Market Expansion
Finerenone is already approved for treating adult patients with chronic kidney disease associated with type 2 diabetes in more than 95 countries worldwide, including China, Europe, Japan, and the United States. Beyond the recent Japanese approval and pending European approval, the drug is also approved for heart failure treatment in the United States, with applications under review in additional markets including China.
The European Commission's final decision on the CHMP positive opinion is expected within the coming weeks, potentially expanding access to this novel therapy for millions of European patients with heart failure and preserved or mildly reduced ejection fraction.