Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF)
Shots:
- The EMA received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits approval in US and China, with global applications planned
- Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed finerenone (QD) vs PBO in pts (n=6000) with HF as well as LVEF of ≥40%, who received diuretic therapy for ≥30 days before randomization
- Study showed improved CV outcomes. Data was presented at ESC Congress 2024 & was published in The NEJM
Ref: Bayer | Image: Bayer
Related News:- Bayer Reports the P-III (FINEARTS-HF) Study Data of Finerenone to Prevent Heart Failure with Preserved Ejection Fraction
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
