
Bayer has officially submitted a marketing authorization application to the European Medicines Agency (EMA), seeking approval for the use of finerenone in adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40% or greater. This patient group includes those diagnosed with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). If approved, finerenone could represent a groundbreaking new treatment option for these underserved heart failure populations, providing new hope for patients facing limited therapeutic choices.
Understanding Finerenone and Its Mechanism of Action
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA). It is the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF and LVEF ≥40%. This drug has already been approved and marketed under the brand names Kerendia™ and Firialta™ in multiple countries, including China, Japan, the U.S., and the European Union, for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
The mineralocorticoid receptor plays a crucial role in regulating blood pressure, inflammation, and fibrosis. Overactivation of this receptor has been linked to the progression of both chronic kidney disease and heart failure. Finerenone works by selectively inhibiting MR activation, reducing inflammation and fibrosis in the heart and kidneys, which contributes to better cardiovascular and renal outcomes. By addressing multiple pathological mechanisms of heart failure, finerenone has the potential to become a key therapeutic option for HF patients with an LVEF ≥40%.
The Clinical Evidence: Insights from the FINEARTS-HF Study
The Phase III FINEARTS-HF trial was designed to evaluate the efficacy and safety of finerenone in patients with HF and LVEF ≥40%. The results demonstrated a statistically significant improvement in cardiovascular outcomes compared to placebo. Patients receiving finerenone experienced fewer cardiovascular-related hospitalizations, better symptom management, and an overall reduction in mortality rates.
Specifically, the study showed:
- A meaningful reduction in the risk of cardiovascular death or HF hospitalization compared to placebo.
- Improved quality of life and functional capacity in patients treated with finerenone.
- A well-tolerated safety profile consistent with previous studies on finerenone, with no unexpected adverse effects.
These findings represent a significant milestone in the management of HF with LVEF ≥40%, which has historically been a challenging condition to treat due to the lack of effective therapies.
The Growing Burden of Heart Failure in Europe and Worldwide
Heart failure is a leading global health concern, affecting more than 60 million people worldwide and at least 15 million individuals in Europe. This chronic and progressive disease significantly impacts patients’ quality of life and imposes a substantial economic burden on healthcare systems. Among all HF patients, nearly half have an LVEF ≥40%, which presents unique treatment challenges due to its association with multiple comorbidities such as obesity, diabetes, and hypertension.
Patients with HF and LVEF ≥40% experience frequent hospitalizations and have a high risk of disease progression, further exacerbating healthcare costs. Studies estimate that heart failure-related expenditures in the EU reach approximately 29 billion euros annually, with repeat hospital admissions accounting for a large proportion of these costs.
A New Pillar in Heart Failure Management
Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, emphasized the significance of finerenone in this underserved patient group. She stated, “Treating heart failure with an LVEF of 40% or greater poses unique challenges, leaving patients with few effective therapeutic options. If approved, finerenone has the potential to become a new pillar in addressing this common form of heart failure, offering hope for improved outcomes in a patient population that has long been underserved.”
Finerenone’s dual impact on cardiovascular and renal health offers a novel approach to managing HF and LVEF ≥40%. Unlike traditional therapies that primarily focus on symptom control, finerenone directly targets underlying disease mechanisms, addressing fibrosis and inflammation, key contributors to HF progression.
Regulatory Approvals and Global Expansion
Bayer has also submitted finerenone for marketing authorization in the U.S. and China, with ongoing reviews in multiple other countries. These regulatory applications are supported by robust data from the FINEARTS-HF study, which is part of the broader MOONRAKER clinical trial program.
MOONRAKER is one of the most comprehensive Phase III heart failure programs to date, enrolling over 15,000 patients worldwide. This extensive research initiative aims to provide a thorough understanding of finerenone’s role in HF treatment across diverse patient populations and clinical settings. The outcomes of these studies will further reinforce finerenone’s potential as a transformative therapy in HF management.
Addressing the Unmet Needs in HF Treatment
Despite advances in heart failure management, HF patients with LVEF ≥40% continue to face significant unmet medical needs. Current treatment guidelines have limited recommendations for this patient group, with few therapies demonstrating consistent benefits in clinical trials. As a result, the approval of finerenone could mark a paradigm shift in HF treatment, offering a new evidence-based option for improving patient outcomes.
Finerenone’s approval could lead to:
- Expanded treatment options for patients with HFmrEF and HFpEF.
- Reduced hospitalization rates and healthcare costs.
- Improved patient quality of life and long-term survival.