European Commission Approves Bayer’s Kerendia for Heart Failure Treatment

The European Commission granted approval on March 30, 2026, for the expanded use of Kerendia (finerenone) to treat adults with heart failure (HF) who have a left ventricular ejection fraction (LVEF) of 40 percent or higher. This regulatory decision extends the application of the medication to patients with heart failure with mildly reduced (HFmrEF) or preserved LVEF (HFpEF).

Kerendia is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA). Under the new EU indication, the medication is approved for use in 10 mg, 20 mg, and 40 mg doses to treat symptomatic chronic heart failure in adults within the specified LVEF category.

Clinical Evidence and the FINEARTS-HF Study

The European Commission’s decision was based on results from the phase III FINEARTS-HF study. This clinical trial evaluated the efficacy of finerenone when added to standard therapy.

The study demonstrated that finerenone significantly reduced a composite endpoint consisting of cardiovascular death and total heart failure events. These events included both first and recurrent occurrences, such as urgent visits and hospitalizations, when compared to a placebo group.

Addressing Heart Failure with Preserved Ejection Fraction

Heart failure affects more than 64 million people worldwide, with at least 15 million people living with the condition in Europe. Approximately half of these patients have an LVEF of 40 percent or greater.

Patients in this specific group often face complex clinical challenges due to accompanying comorbidities. Common conditions that burden this population include hypertension, atrial fibrillation, and chronic kidney disease (CKD), all of which contribute to increased mortality and higher rates of hospitalization.

Patients with heart failure with left ventricular ejection fraction of 40% or greater represent a large and growing group of patients with a poor prognosis who face substantial clinical challenges including repeat hospitalizations for worsening heart failure, and high mortality risk

Scott D. Solomon, MD, Professor of Medicine, Harvard Medical School, Director, Clinical Trials Outcomes Center, Mass General Brigham, and Chair of the study’s Executive Committee

Current projections suggest that this patient population will represent the majority of heart failure hospitalizations in the near future, despite limited treatment options previously available for those with preserved or mildly reduced ejection fractions.

Expansion of Therapeutic Scope

Prior to this European Commission approval, Kerendia was primarily indicated for the treatment of adults with chronic kidney disease associated with type 2 diabetes. Finerenone is already marketed in more than 100 countries, including the United States, Japan, China, and other European nations, under the brand name Kerendia or, in certain regions, Firialta.

The expansion into heart failure treatment marks a significant shift in the drug’s clinical application, broadening its utility beyond metabolic and renal health into cardiovascular care.

Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, stated that the approval is excellent news for millions of patients in Europe with heart failure and left ventricular ejection fraction of ≥40%.

The addition of this indication is intended to provide more treatment options for eligible patients across the European Union to help improve their overall clinical outcomes.