Bayer Finerenone secures USFDA Priority Review designation for heart failure
Berlin: Bayer has announced that the Company has received Priority Review designation from the U.S. Food and Drug Administration (FDA) for finerenone for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).
The regulatory submission was based on the positive results from the Phase III FINEARTS-HF study, detailed results of which were presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF and an LVEF of ≥40% in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.
By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%.
The supplemental New Drug Application submitted to the U.S. FDA is based on positive data from the FINEARTS-HF study, which is part of the ongoing MOONRAKER study program with finerenone. Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU, and Japan, and these applications are currently under review. Further regulatory applications to health authorities in other markets worldwide will follow.
