Bayer's Finerenone Receives FDA Priority Review for Heart Failure with LVEF ≥40%

On March 17 local time, Bayer announced that the FDA had acceptedFinerenone(Finerenone)Supplemental New Drug Application(sNDA)`, and granted it priority review status, for`TreatmentLeft Ventricular Ejection Fraction（LVEF） ≥40% of adult heart failure patients, that is, mild reduction in left ventricular ejection fraction（HFmrEF）Or left ventricular ejection fraction preserved（HFpEF）Patients with heart failure.

Notably, the marketing application for this indication in China was accepted by the CDE on January 24, 2025. The Insight database speculates that it will be approved for marketing in 2026.

Screenshot source: Corporate official website

This timesNDA Is based on the positive results of the Phase III FINEARTS-HF study. This study is part of the ongoing MOONRAKER research program and is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III clinical trial aimed at investigating the efficacy and safety of Finerenone in preventing cardiovascular death and heart failure (HF) events. The study'sThe primary endpoint is cardiovascular death and total HF.Number of Events, defined as hospitalization for HF or emergency HF visit.

Data show that, compared with placebo combined with conventional treatment, FinerenoneSignificantly reduced cardiovascular death and total(First and Recurrent)Comprehensive Incidence Rate of Heart Failure Events, approximately half of HF patients have left ventricular ejection fraction (LVEF) Mildly reduced or preserved, i.e., LVEF ≥40%.

However, the currently available approved and guideline-directed treatment options are limited. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) Antagonist, isThe first MR antagonist to demonstrate clear cardiovascular benefits in patients with LVEF ≥40% in a Phase III study。

The drug was first approved for marketing by the US FDA in July 2021 for the treatment ofDiabetic NephropathySales reached 4.63 billion in 2024.Billion euros，Up 71.5% year-on-year。

Screenshot source: Corporate earnings report

Cover Source:Corporate logo

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