European Commission approves Kerendia (finerenone) for heart failure with LVEF ≥40%, backed by Phase III FINEARTS-HF data showing reduced CV death and HF events.
Written By: Anand Sathappan, BPharm
Reviewed By: Pharmacally Editorial Team
The European Commission has approved Kerendia (finerenone) for the treatment of adults with symptomatic chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, significantly expanding its use beyond chronic kidney disease linked to type 2 diabetes. The decision positions finerenone as a new therapeutic option for patients with mildly reduced or preserved ejection fraction.
Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist that targets mineralocorticoid receptor overactivation, a central driver of cardiovascular and renal damage. By addressing this pathway, the drug aims to reduce disease progression and improve outcomes in a population that continues to face limited treatment options.
The approval is supported by results from the pivotal Phase III FINEARTS-HF trial (NCT04435626). The study demonstrated that finerenone significantly reduced the composite risk of cardiovascular death and total heart failure events, including hospitalizations and urgent visits, compared with placebo on top of standard therapy. Benefits were consistent across patient subgroups, irrespective of background treatments, comorbidities, or baseline use of SGLT-2 inhibitors.
Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer, emphasized that this expanded indication represents an important step in improving access for a large and underserved heart failure population in Europe. She also noted that finerenone has shown consistent reductions in cardiovascular death and heart failure events across clinical settings, supported by evidence from five Phase III trials. This breadth of data reinforces Kerendia’s potential to become a foundational therapy across both heart failure with LVEF ≥40% and chronic kidney disease.
Heart failure with LVEF ≥40% represents a large and growing patient population, often complicated by comorbidities such as chronic kidney disease, hypertension, and atrial fibrillation. These patients experience frequent hospitalizations and high mortality yet have relatively few guideline-directed therapies. The burden is substantial, with heart failure affecting over 64 million people globally, and healthcare costs in Europe alone estimated at €29 billion annually.
Across multiple Phase III studies, finerenone has demonstrated cardiovascular and renal benefits in diverse populations, including diabetic and non-diabetic kidney disease as well as heart failure.
The FINEARTS-HF results were presented at the ESC Congress 2024 and simultaneously published in the The New England Journal of Medicine, underscoring the strength of the clinical evidence. The study forms part of the broader MOONRAKER program, one of the largest Phase III clinical trial programs in heart failure to date, enrolling over 15,000 patients. This extensive program is designed to build a comprehensive understanding of finerenone across a wide spectrum of heart failure populations and clinical settings, further supporting its role in future treatment strategies.
Reference
Kerendia™ approved in EU for new indication in adult patients with heart failure with LVEF ≥40%, 30 March 2026, Kerendia™ approved in EU for new indication in adult patients with heart failure with LVEF ≥40%
Scott D. Solomon et al, Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction, N Engl J Med 2024;391:1475-1485, https://www.nejm.org/doi/full/10.1056/NEJMoa2407107
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF), ClinicalTrials.gov ID NCT04435626, https://clinicaltrials.gov/study/NCT04435626
About the Writer
Anand Sathappan is a pharmacy graduate with interests in pharmaceutical sciences, pharmacology, and medical writing. He also holds certification in medical coding and has familiarity with pharmacology and healthcare documentation. His work focuses on exploring developments in pharmaceuticals and presenting scientific information in a clear and structured manner.