Topline Data Prove Finerenone's HFpEF Benefit in FINEARTS-HF Trial

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Finerenone (Kerendia) met its primary endpoint, a significant reduction in the composite of cardiovascular death and total heart failure events in the FINEARTS-HF trial, according to an August 05, 2024 announcement from Bayer.

Already boasting US Food and Drug Administration (FDA) approvals for chronic kidney disease in patients with type 2 diabetes, topline data from the FINEARTS-HF trial signal a new role in the management of another cardiometabolic disease could come in the near future. According to Bayer, which is due to present the trial at the upcoming European Society of Cardiology congress, the company plans to discuss the data and submission for regulatory approval with the FDA.^1,2

“Bayer is determined to drive research and innovations that have the potential to become treatment options for diseases with high unmet medical need, including for patients with mildly reduced or preserved ejection fraction,” said Christian Rommel, PhD, head of Research and Development at Bayer’s Pharmaceuticals Division.¹

A non-steroidal, selective mineralocorticoid receptor antagonist, finerenone began to draw attention of the medical community with its clinical trial program, which included the FIDELIO-DKD and FIGARO-DKD trials. These trials were subsequently used as the basis of an application and eventual approval of finerenone for chronic kidney disease in type 2 diabetes in July 2021. These, plus FINEARTS-HF, represent 3 ongoing trials or programs examining use of finerenone, including the FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, the Phase II study, CONFIDENCE, REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF.^1,2

FINEARTS-HF was a randomized, double-blind, placebo-controlled, multicenter, event-driven phase 3 trial enrolling around 6000 patients with a diagnosis of New York Heart Association class II-IV heart failure with a left ventricular ejection fraction (LVEF) of 40% or greater, and receiving diuretic treatment for at least 30 days prior to randomization. These patients were randomized in a 1:1 ratio to finerenone or placebo and subsequently followed for up to 42 months for a primary composite endpoint of cardiovascular death and total heart failure events, which investigators defined as hospitalizations for heart failure or urgent heart failure visits.¹

Results announced by Bayer on August 05, 2024 indicated FINEARTS-HF met its primary endpoint with finerenone achieving a statistically significant reduction of the composite of cardiovascular death and total heart failure events. According to Bayer, results make finerenone the first non-steroidal, selective mineralocorticoid receptor antagonist to meet a primary cardiovascular endpoint in a phase 3 trial in heart failure with mildly reduced or preserved ejection fraction.¹

References:

1. Bayer Pharmaceuticals. Bayer announces primary endpoint achieved in phase III FINEARTS-HF cardiovascular outcomes study investigating kerendia® (finerenone) in patients with heart failure with mildly reduced or preserved ejection fraction. Business Wire. August 5, 2024. Accessed August 5, 2024. https://www.businesswire.com/news/home/20240804941740/en/Bayer-Announces-Primary-Endpoint-Achieved-in-Phase-III-FINEARTS-HF-Cardiovascular-Outcomes-Study-Investigating-KERENDIA%C2%AE-finerenone-in-Patients-with-Heart-Failure-with-Mildly-Reduced-or-Preserved-Ejection-Fraction.
2. Center for Drug Evaluation and Research. FDA approves drug for chronic kidney disease. U.S. Food and Drug Administration. July 9, 2021. Accessed August 5, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease.