Bayer: FDA grants priority review

(CercleFinance.com) - Bayer announces that the US FDA has granted priority review for a new indication for finerenone in heart failure patients.


The group states in its press release that finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in heart failure (HF) patients with a left ventricular ejection fraction (LVEF) of ≥40%.

The regulatory submission was based on positive results from the Phase III FINEARTS-HF study, the results of which were presented at ESC 2024 and simultaneously published in the New England Journal of Medicine.

Approximately 6.7 million people in the US suffer from heart failure, and more than half of these patients have CHF with an LVEF of ≥40%.

The FDA's priority review designation reinforces finerenone's potential to become a new therapeutic pillar, advancing the treatment paradigm for heart failure with a left ventricular ejection fraction (LVEF) of ≥40%, Bayer said.

Currently, treatment options with proven efficacy are limited for physicians. We are delighted with the priority review designation for finerenone, as this brings us one step closer to making finerenone available to patients as quickly as possible, it adds.


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