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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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