Bayer files for approval of finerenone in heart failure in the EU

Bayer

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.

Read Bayer press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier , Registration