Finerenone significantly improves cardiovascular outcomes in adults with common heart failure

Finerenone, a novel mineralocorticoid receptor (MR) antagonist, has demonstrated significant cardiovascular benefits in a Phase III study for patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of 40% or higher, indicating either mildly reduced or preserved LVEF. The study, named FINEARTS-HF, showcased a 16% relative risk reduction in the composite primary endpoint of cardiovascular death and total heart failure events compared to a placebo, marking a substantial advancement in the treatment of this form of heart failure.

The FINEARTS-HF study's primary endpoint results were consistent across various subgroups, including those defined by comorbidities, hospitalization status, ejection fraction, or baseline use of SGLT2-inhibitors. Additionally, the study's findings were concurrently published in the New England Journal of Medicine. The high rates of hospitalization and mortality for patients with HF and an LVEF of 40% or greater underscore the significant unmet medical need, which currently has only limited approved treatment options.

Detailed results from the FINEARTS-HF study, presented at the ESC Congress 2024, revealed that finerenone significantly improved cardiovascular outcomes over a median duration of 32 months. The drug reduced the risk of cardiovascular death and total heart failure events, defined as hospitalizations for HF or urgent HF visits, by 16%. This makes finerenone the first MR antagonist to show definitive cardiovascular benefits in this patient category.

Scott D. Solomon, MD, from Harvard Medical School, emphasized the high unmet medical need for treating heart failure patients with LVEF of 40% or higher, highlighting the lack of proven treatments for this population. If approved, finerenone could provide a valuable treatment option for these patients.

The benefits of finerenone were consistent across all prespecified subgroups, regardless of background therapy, comorbidities, or hospitalization status. The drug also significantly reduced secondary endpoints, such as total heart failure events and improved patient-reported health status, measured by the Kansas City Cardiomyopathy Questionnaire's Total Symptom Score.

Heart failure affects over 60 million people worldwide, with about half suffering from HF with an LVEF of 40% or higher. This condition is complex to manage due to multimorbidity and is associated with high hospitalization and mortality rates. Despite available treatments, the risk of cardiovascular events and mortality remains high for these patients.

Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, emphasized Bayer's commitment to cardiology and heart failure. Rommel highlighted that the FINEARTS-HF study included a high percentage of hospitalized or recently hospitalized patients, making the results particularly relevant for improving cardiovascular outcomes in this challenging patient population.

Finerenone, a non-steroidal, selective MR antagonist, targets MR and renin-angiotensin-aldosterone system (RAAS) overactivation, addressing key factors in heart failure with an LVEF of 40% or higher, such as fibrotic drivers. The drug was well-tolerated in the study, with a comparable overall incidence of serious adverse events between the finerenone and placebo groups. Hyperkalemia-related adverse events were more frequent in the finerenone group but were generally manageable.

Bayer plans to seek marketing authorization for finerenone for heart failure with an LVEF of 40% or higher. The FINEARTS-HF study is part of the larger MOONRAKER clinical trial program, which aims to provide a comprehensive understanding of finerenone in heart failure across various patient groups and clinical settings.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!