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 % 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 today 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 ≥ 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 ≥ 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.”

"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 ≥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 both 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.