Introduction to Heart Failure and the Need for New Treatments
Bayer has announced that it has submitted marketing authorization applications to both the U.S. Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE), seeking approval for finerenone as a treatment for adults with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%.
This includes individuals with mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF). Finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), is the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with this common form of heart failure, based on the Phase III FINEARTS-HF study.
Finerenone is already marketed as Kerendia™ (or Firialta™ in some countries) and has been approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in over 90 countries, including China, Europe, Japan, and the U.S. With the recent submissions to the FDA and CDE, Bayer is seeking to expand the approved uses of finerenone to include the treatment of patients with an LVEF of ≥40%.
A significant global health issue, affecting over 60 million people worldwide, and is becoming an increasingly urgent public health concern. Approximately half of these patients have HF with a LVEF of ≥40%, which includes both mildly reduced and preserved LVEF cases. This subset is often challenging to manage due to the presence of multiple comorbidities, making treatment difficult and complex. Over time, this population is expected to represent the majority of patients hospitalized for heart failure.
Finerenone works by targeting the mineralocorticoid receptor (MR) and addressing the overactivation of the renin-angiotensin-aldosterone system (RAAS). This mechanism helps address key aspects of with a LVEF of ≥40%, such as hemodynamic factors, inflammation, and fibrotic processes. The Phase III FINEARTS-HF study demonstrated that finerenone led to a statistically significant improvement in cardiovascular outcomes in patients with heart failure and an LVEF of ≥40%, compared to a placebo.
The submissions to both the FDA and the CDE are based on the promising results from the FINEARTS-HF study, which is part of one of the largest Phase III clinical trial programs to date for heart failure. The program involved more than 15,000 patients and aimed to provide a comprehensive understanding of how finerenone works in heart failure patients across a variety of clinical settings.
Phase III FINEARTS-HF Study and Its Impact on Heart Failure Treatment
The Phase III FINEARTS-HF study is pivotal in evaluating finerenone’s potential to improve outcomes for patients with heart failure with a LVEF of ≥40%, particularly those with high unmet medical needs. The study was designed to address the growing population of heart failure patients who have a LVEF of ≥40%, a condition that has traditionally been under-researched and lacks effective treatment options.
Finerenone’s demonstrated ability to improve cardiovascular outcomes in this patient population is significant, as these patients are often underserved in terms of treatment options. If approved, finerenone could become an important new pillar in the treatment of heart failure with preserved and mildly reduced LVEF, offering new hope to patients with limited treatment options and no proven therapies to improve their cardiovascular outcomes.
Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, commented on the importance of this submission. She noted that heart failure, particularly in patients with an LVEF of ≥40%, represents a serious global health challenge, as these patients are difficult to treat and often face limited options. If approved, she believes that finerenone could help address this significant unmet need and offer patients a new treatment option with proven efficacy.
The global impact of heart failure cannot be overstated. As a progressive and often debilitating condition, heart failure with a preserved or mildly reduced LVEF is growing rapidly. As of now, treatments for this specific population remain inadequate, making the development of finerenone an exciting prospect for improving patient outcomes. Finerenone’s ability to target the MR pathway and RAAS overactivation may provide a novel approach to managing the underlying causes of heart failure, potentially slowing disease progression and improving quality of life for patients.
Heart failure with preserved or mildly reduced LVEF is a condition often associated with additional comorbidities such as hypertension, diabetes, and chronic kidney disease. These factors complicate the management of heart failure, further highlighting the need for effective therapies. Current treatments for heart failure largely focus on patients with a reduced LVEF (HFrEF), leaving patients with an LVEF of ≥40% with few options. By targeting the MR pathway, finerenone offers a promising new avenue for addressing these challenges.
As the population of heart failure patients with preserved and mildly reduced LVEF continues to grow, the need for effective treatments is becoming more urgent. The submission of the marketing authorization applications for finerenone is a significant step in addressing this need.
If approved by regulatory authorities in the U.S. and China, finerenone has the potential to improve the cardiovascular outcomes of millions of patients, changing the landscape of treatment for heart failure with a preserved or mildly reduced LVEF.
The potential of finerenone is further supported by its demonstrated safety and efficacy in clinical trials. The FINEARTS-HF study was carefully designed to evaluate the drug’s impact on cardiovascular outcomes, with a focus on the most important clinical endpoints for heart failure patients.
The results of this study are expected to play a critical role in shaping the future of heart failure treatment, providing evidence of the drug’s ability to improve patient outcomes in a challenging and often underserved population.
Bayer’s submission of marketing authorization applications for finerenone in the U.S. and China represents a promising advancement in the treatment of heart failure with a preserved or mildly reduced LVEF. With over 60 million people affected by heart failure worldwide, the potential to offer an effective treatment for this growing population is significant.
Finerenone’s ability to improve cardiovascular outcomes in patients with high unmet medical needs could position it as a new standard of care for heart failure, providing hope to patients who currently have limited treatment options. The upcoming regulatory reviews will be critical in determining whether finerenone can fulfill its promise as a groundbreaking therapy for heart failure patients globally.
