USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure

Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) and granted Priority Review designation for finerenone for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).

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

The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would offer significant improvements in the efficacy or safety of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies. Based on a priority review designation, the FDA’s goal is to take action on a New Drug Application within 6 months of submission, compared to 10 months under standard review. This would result in a PDUFA date and a potential approval of Kerendia in the U.S. in heart failure with an LVEF of ≥40% in the third quarter of 2025.

“The FDA’s Priority Review designation reinforces the potential of finerenone to emerge as a new pillar of therapy, advancing the treatment paradigm in heart failure with a left ventricular ejection fraction (LVEF) of ≥40%,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Currently, there are limited treatment options with proven efficacy available to physicians. We are excited about the Priority Review designation for finerenone, as this brings us an important step closer to bringing finerenone to patients as quickly as possible."

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF and an LVEF of ≥40% in the Phase III study FINEARTS-HF.