Finerenone showed statistically significant improvement in cardiovascular outcomes in adults with common form of heart failure with high unmet medical need – Bayer

Detailed results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone (Kerendia/ Firialta) showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%. Finerenone significantly reduced the risk of the composite primary endpoint of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits, by 16 % (relative risk reduction, rate ratio (RR) 0.84 [95% CI, 0.74-0.95; p=0,0072]) over a median duration of 32 months.

Based on the results of FINEARTS-HF, finerenone is the first MR antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with this common form of heart failure. The FINEARTS-HF findings were presented during a Hot Line session at ESC Congress 2024 and simultaneously published in the New England Journal of Medicine.

“Treating heart failure patients with LVEF greater than 40% has provided a significant challenge for many physicians, and there is a high unmet medical need as these patients have a substantial risk for serious cardiovascular events. Unlike heart failure with reduced ejection fraction, where many treatments are now available, for heart failure with LVEF greater than 40%, we currently have limited treatment options with proven efficacy,” said Scott D. Solomon, MD, The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Senior Physician at Brigham and Women’s Hospital and Chair of the study’s Executive Committee. “With FINEARTS-HF as the first large-scale study of a non-steroidal, selective mineralocorticoid receptor antagonist in these underserved heart failure patients, finerenone, if approved, has the potential to help these vulnerable patients.”

The benefits shown in the primary endpoint were consistent across all prespecified subgroups, regardless of background therapy, comorbidities, or hospitalization status, including those based on disease state (ejection fraction) or baseline use of SGLT2-inhibitors.

Finerenone also significantly reduced the secondary endpoints of total HF events (RR 0.82 [95% CI, 0.71-0.94; p=0.0062]) and improved patient-reported health status as measured by the change from baseline in Total Symptom Score of Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS), (between-group difference 1.6 points [95% CI, 0.8-2.3; p<0.0001]).

Heart failure (HF) affects over 60 million people worldwide; approximately half of these patients suffer from HF with a LVEF of greater than 40%. HF with a LVEF greater than 40% is associated with multi-morbidity, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF. Patients with HF LVEF greater than 40% have similar hospitalization and mortality rates as those with HF LVEF less than 40% (HF with reduced ejection fraction, HFrEF). More than half of patients with HF LVEF greater than 40% will die within 5 years. The high residual risk of CV events and mortality remains high despite available treatments in patients with HF LVEF greater than 40%.

“Bayer has a strong heritage in cardiology, and heart failure is a key focus area for us, with these promising results underpinning our ongoing commitment to patients with this devastating condition. In FINEARTS-HF, finerenone reduced cardiovascular outcomes in a complex to treat patient population. This confirms the potential of finerenone, if approved, as a valuable treatment option in heart failure with mildly reduced or preserved ejection fraction irrespective of background therapy and disease state,” said Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division. “FINEARTS-HF included a high percentage of hospitalized or recently hospitalized patients, which means the results are highly relevant for improving cardiovascular outcomes for patients who do not have enough options.”

Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist. By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses hallmarks of HF with a LVEF greater than 40%, such as fibrotic drivers.

Finerenone was well-tolerated in the FINEARTS-HF study, which is consistent with the well-established safety profile of finerenone. The overall incidence of treatment-emergent serious adverse events was comparable between finerenone and placebo groups. Hyperkalemia-related adverse events occurred more frequently with finerenone than placebo (9.7 % and 4.2%, respectively). There were no fatal adverse events of hyperkalemia in either treatment group, and hospitalization or discontinuation due to hyperkalemia was rare. The occurrence of increased potassium and creatinine levels was also more frequent in the finerenone group, but the incidence of potassium above 6.0 mmol/L was generally low.

Bayer plans to submit applications for marketing authorization for finerenone for an indication in heart failure with a LVEF of ?40% to health authorities in due course.

See-

“Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction”-Authors: Scott D. Solomon, M.D. , John J.V. McMurray, M.D. , Muthiah Vaduganathan, M.D., M.P.H., Brian Claggett, Ph.D., Pardeep S. Jhund, M.B., Ch.B., Ph.D., Akshay S. Desai, M.D., M.P.H., Alasdair D. Henderson, Ph.D., +52, for the FINEARTS-HF Committees and Investigators
Published September 1, 2024. DOI: 10.1056/NEJMoa2407107.