3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine.
Bayer today announced the submission of a marketing authorization application to the EMA, seeking approval in the EU for the use of finerenone in adult patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF or preserved LVEF.