Posted by Michael Wonder on 15 Jul 2025
US FDA approves finerenone for new indication in patients with heart failure with left ventricular ejection fraction of ≥40%
14 July 2025 - New indication approval follows the US FDA’s priority review designation and is based on positive results from the Phase 3 FINEARTS-HF study, which is part of the on-going MOONRAKER program – one of the largest Phase 3 clinical trial programs to date in heart failure.
Bayer announced today that the US FDA has approved finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with heart failure and a left ventricular ejection fraction of ≥40%.
