Posted by Michael Wonder on 19 Mar 2025
US FDA grants priority review for new indication of finerenone for patients with common form of heart failure
17 March 2025 - Regulatory submission is based on positive results from the Phase 3 FINEARTS-HF study, which is part of the on-going Phase 3 clinical trial program MOONRAKER – one of the largest Phase III clinical trial programs to date in heart failure.
Bayer announced today that the US FDA has accepted its supplemental new drug application and granted Priority Review designation for finerenone for the treatment of adult patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF or preserved LVEF.
