Top-line results: Finerenone reduces events in certain patients with heart failure
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Key takeaways:
- Finerenone reduced risk for heart-related death and HF events in certain patients with HF.
- Bayer will seek approval for finerenone to treat patients with HF and preserved or mildly reduced ejection fraction.
Bayer announced positive top-line results for the FINEARTS-HF trial of finerenone, in which the drug reduced risk for cardiovascular death and heart failure events in patients with HF with preserved or mildly reduced ejection fraction.
The full results of the randomized, double-blind, placebo-controlled, phase 3 FINEARTS-HF trial will be presented at the European Society of Cardiology Congress in September, according to a press release from the company.
The primary endpoint, a composite of CV death and total (first or recurrent) HF events, defined as HF hospitalizations or urgent HF visits, was significantly reduced in patients with HF and left ventricular EF 40% or more who were assigned finerenone (Kerendia), a nonsteroidal, selective mineralocorticoid receptor antagonist, compared with those assigned placebo, the company stated in the release.
There were no safety signals observed with finerenone in FINEARTS-HF beyond those already seen in previous studies, according to the release.
Finerenone is currently approved for reduction of CV death, nonfatal myocardial infarction, hospitalization for HF, sustained decline in estimated glomerular filtration rate and end-stage kidney disease in adult patients with chronic kidney disease associated with type 2 diabetes.
Bayer stated in the release that it plans to discuss with the FDA submission for regulatory approval of finerenone for patients with HF with preserved or mildly reduced EF.
FINEARTS-HF is part of the MOONRAKER program, which is evaluating finerenone in more than 15,000 patients with HF across various populations and clinical settings, according to the release.
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