Kerendia™ Receives EU Approval for Expanded Use in Adults with Heart Failure and LVEF ≥40%
Bayer has achieved a major regulatory milestone with the approval of Kerendia (finerenone) by the European Commission for an expanded indication in the European Union. The decision allows the therapy to be used for the treatment of adult patients with symptomatic chronic Heart Failure who have a left ventricular ejection fraction (LVEF) of 40% or greater, a category that includes both heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF).
This approval represents a significant broadening of Kerendia’s clinical utility. Previously authorized in the EU for patients with chronic kidney disease (CKD) associated with type 2 diabetes, the drug can now be used in a much larger population of cardiovascular patients. The updated label includes multiple dose strengths—10 mg, 20 mg, and 40 mg—and positions finerenone as a new therapeutic option for individuals living with heart failure who continue to face substantial unmet medical needs.
Addressing a Growing and Challenging Patient Population
Heart failure remains one of the most pressing global health challenges, affecting more than 64 million people worldwide. Within Europe alone, at least 15 million individuals are living with the condition. Notably, approximately half of these patients fall into the category of having an LVEF of 40% or higher. This subgroup has historically been difficult to treat due to the complexity of the disease and the limited number of effective, guideline-directed therapies available.
Patients with HFmrEF and HFpEF often present with multiple coexisting conditions, including chronic kidney disease, hypertension, and atrial fibrillation. These comorbidities contribute to a higher risk of hospitalization and mortality, creating a significant burden on both patients and healthcare systems. Recurrent hospital admissions are particularly common in this population and are a major driver of healthcare costs. In the European Union, heart failure-related expenditures are estimated to reach approximately €29 billion annually.
Scott D. Solomon, Professor of Medicine at Harvard Medical School and Director of the Clinical Trials Outcomes Center at Mass General Brigham, emphasized the urgent need for new treatment options in this space. He highlighted that patients with LVEF ≥40% represent a large and growing segment of the heart failure population with poor prognoses, characterized by frequent hospitalizations and elevated mortality risk.
According to Dr. Solomon, finerenone directly targets mineralocorticoid receptor overactivation, a key biological driver of disease progression in heart failure. By addressing this pathway, the therapy offers a novel mechanism of action that complements existing treatments and has the potential to significantly improve patient outcomes.
Clinical Evidence from the FINEARTS-HF Trial
The European Commission’s approval is grounded in robust clinical evidence, particularly from the pivotal Phase III FINEARTS-HF study. This large-scale trial evaluated the efficacy and safety of finerenone in patients with heart failure and LVEF ≥40%, assessing its impact when added to standard-of-care therapies.
The study successfully met its primary endpoint, demonstrating that finerenone significantly reduced the combined risk of cardiovascular death and total heart failure events. These events included both initial and recurrent hospitalizations for heart failure, as well as urgent healthcare visits related to worsening symptoms.
Importantly, the benefits observed with finerenone were consistent across a wide range of patient subgroups. This included individuals with varying levels of ejection fraction, different comorbid conditions, and those receiving concurrent therapies such as SGLT-2 inhibitors. The consistency of these findings underscores the broad applicability of finerenone in real-world clinical settings.
The results of the FINEARTS-HF trial were presented at the ESC Congress 2024 and simultaneously published in the New England Journal of Medicine, further reinforcing the scientific credibility and clinical significance of the data.
Part of the Expansive MOONRAKER Program
FINEARTS-HF is a central component of Bayer’s ambitious MOONRAKER clinical development program, one of the largest Phase III trial initiatives ever conducted in heart failure. Encompassing more than 15,000 patients across multiple studies, the program is designed to provide a comprehensive understanding of finerenone’s role in treating heart failure across diverse patient populations and clinical scenarios.
Beyond heart failure, finerenone has been extensively studied in patients with chronic kidney disease, both with and without diabetes. Across five pivotal Phase III trials involving over 20,000 participants, the drug has consistently demonstrated cardiovascular and renal benefits. This extensive evidence base highlights the potential of finerenone to serve as a foundational therapy across multiple interconnected disease areas.
Mechanism of Action and Therapeutic Potential
Finerenone belongs to a class of medications known as non-steroidal mineralocorticoid receptor antagonists (nsMRAs). Unlike traditional steroidal MRAs, finerenone is designed to selectively block the mineralocorticoid receptor with improved specificity, reducing inflammation and fibrosis in cardiovascular and renal tissues.
Overactivation of the mineralocorticoid receptor is a well-recognized contributor to disease progression in both heart failure and kidney disease. By targeting this pathway, finerenone helps to mitigate structural and functional damage, thereby improving clinical outcomes.
Its unique pharmacological profile, combined with strong clinical data, positions Kerendia as a potential cornerstone therapy in the management of patients with heart failure and reduced or preserved ejection fraction, as well as those with chronic kidney disease.
Industry and Company Perspective
Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, described the approval as a major advancement for patients across Europe. She emphasized that millions of individuals with heart failure and LVEF ≥40% now have access to a new treatment option that has demonstrated meaningful clinical benefits.
Roth also highlighted that finerenone’s efficacy in reducing the risk of cardiovascular death and heart failure events was observed regardless of background therapy or clinical setting. This versatility makes it a valuable addition to existing treatment regimens and supports its integration into standard clinical practice.
Furthermore, she noted that the breadth of evidence generated from multiple Phase III studies reinforces the potential of Kerendia to become an essential component of care not only for heart failure but also for kidney disease.
Expanding Global Access
The European Union approval follows earlier regulatory successes in other regions. Finerenone received approval in the United States in July 2025 for the treatment of heart failure with LVEF ≥40%, following a priority review process. It has also been approved for this indication in Japan and several other markets.
Bayer continues to work with regulatory authorities worldwide to expand access to finerenone, with applications currently under review in additional countries, including China. This global regulatory momentum reflects the growing recognition of the therapy’s clinical value.
Since its initial launch in 2021, finerenone has been marketed under the brand name Kerendia, and in some countries as Firialta. It is already approved in more than 100 countries for the treatment of chronic kidney disease associated with type 2 diabetes, demonstrating its widespread adoption and established role in clinical practice.
The approval of Kerendia for heart failure with LVEF ≥40% marks a pivotal moment in the evolution of cardiovascular care. By addressing a significant unmet need in a large and complex patient population, finerenone has the potential to reshape treatment paradigms and improve outcomes for millions of patients.
As the burden of heart failure continues to rise globally, innovations such as finerenone will play an increasingly important role in managing the disease and reducing its impact on healthcare systems. With its strong clinical foundation, novel mechanism of action, and expanding global reach, Kerendia is well positioned to become a key pillar in the comprehensive management of both heart failure and chronic kidney disease.
Bayer’s continued investment in research and development, combined with its commitment to improving patient access, underscores the company’s leadership in advancing therapies for cardiovascular and renal diseases.
About Kerendia™ / Firialta™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes the completed pivotal Phase III study FINEARTS-HF, as well as the ongoing investigator-sponsored, collaborative studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE, and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies in paediatric patient populations FIONA, and FIONA-OLE.
About FINEARTS-HF
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.
Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.
About Heart Failure
Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 64 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers.
HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation. Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.
Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.
When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:
- Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%
- Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump
- Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%
While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%.
About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future cardiovascular market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth.
Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular and kidney diseases are treated.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses.
At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros.
Source Link:https://www.bayer.com/
