Posted by Michael Wonder on 13 Jan 2025
Bayer submits application to US FDA and to China’s CDE for new indication of finerenone for patients with common form of heart failure with high unmet medical need
10 January 2025 - Regulatory submissions are based on positive data from the Phase 3 FINEARTS-HF study recently presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine.
Bayer today announced the submission of marketing authorisation applications to the US FDA and to the Center of Drug Evaluation of China’s National Medical Products Administration, seeking approval of finerenone in the US and in China for adult patients with HF with a left ventricular ejection fraction of ≥40%, i.e. mildly reduced left ventricular ejection fraction or preserved left ventricular ejection fraction.
