FINEARTS-HF Study Shows Finerenone Cuts CV death and Heart Failure Events in HFmrEF/HFpEF Patients
USA: Topline results from the FINEARTS-HF trial have revealed that finerenone (Kerendia), a nonsteroidal selective mineralocorticoid receptor antagonist (nsMRA), can lower the risk of cardiovascular (CV) death and total heart failure (HF) events in patients with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).
Bayer announced that FINEARTS-HF met its primary endpoint, achieving a statistically significant reduction of the composite of CV death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. The trial found no new safety concerns beyond those identified in previous studies with the drug.
Bayer will present the FINEARTS-HF data at the European Society of Cardiology (ESC) Congress 2024 in September and intends to discuss regulatory approval with the U.S. Food and Drug Administration (FDA) thereafter.
KERENDIA, a non-steroidal selective mineralocorticoid receptor antagonist (MRA), has already demonstrated cardiovascular benefits, including reductions in heart failure hospitalizations, cardiovascular death, and non-fatal myocardial infarction in adults with chronic kidney disease (CKD) and type 2 diabetes (T2D). The new topline data shows positive results for a broader patient population, including those with heart failure and a left ventricular ejection fraction (LVEF) greater than 40%, extending its potential benefits beyond CKD in T2D.
The FINEARTS-HF study is a component of the MOONRAKER program for KERENDIA, anticipated to be one of the largest heart failure research initiatives to date. With over 15,000 patients involved, this program aims to provide a thorough understanding of KERENDIA's effects on heart failure across a wide range of patients and clinical settings.
The FINEARTS-HF trial, a randomized, double-blind, placebo-controlled, parallel-group, multi-center phase III study, assessed the efficacy and safety of KERENDIA (finerenone) for new uses in patients with heart failure and a left ventricular ejection fraction (LVEF) of 40% or higher.
The primary endpoint of the FINEARTS-HF trial was the composite of cardiovascular death and total heart failure (HF) events, which included both first and recurrent HF events such as hospitalizations or urgent HF visits.
In the study, approximately 6,000 patients were randomized to receive either finerenone or a placebo daily for up to 42 months.
Together with other trials in the MOONRAKER clinical program, which includes over 15,000 patients, FINEARTS-HF is part of one of the largest heart failure research initiatives to date. The extensive program aims to build a robust body of evidence for finerenone across a diverse range of patients and clinical situations.
“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,” Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, said in a press release.
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