FRANKFURT—Bayer AG (FRA: BAYN) has announced positive results from the Phase III FINEARTS-HF study for its mineralocorticoid receptor (MR) antagonist, finerenone. Originally approved for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes, finerenone is now being developed for heart failure, a condition with significant market potential.
In the FINEARTS-HF trial, which included approximately 6,000 patients with heart failure and a left ventricular ejection fraction (LVEF) of ≥40%, finerenone demonstrated superior performance over placebo, achieving the primary endpoint by reducing the risk of heart failure events by 16% over 32 months. The study was a randomized, double-blind, placebo-controlled assessment of finerenone’s safety and efficacy in preventing cardiovascular death and heart failure events.
Additionally, finerenone met the secondary endpoint, showing an improvement in patient-reported health status. Safety results indicated a higher incidence of hyperkalemia-related adverse events at 9.7% for finerenone versus 4.2% for placebo, with no fatal cases of hyperkalemia reported in either group.
Bayer highlighted in its press release that while there are numerous treatments available for heart failure with reduced ejection fraction, options for heart failure with LVEF ≥ 40% are limited. The company plans to prepare approval filings for this new indication in the near future, potentially expanding its market reach and offering a new treatment option for patients with heart failure.
Full study details have been published by Bayer in the New England Journal of Medicine, providing further insight into the drug’s performance and safety profile. – Flcube.com
