FDA grants priority review for new indication of finerenone for patients with heart failure and with a left ventricular ejection fraction of ≥40%- Bayer

Bayer announced tthat the 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. 

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.  By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%.

FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities. With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

The supplemental New Drug Application submitted to the U.S. FDA is based on positive data from the FINEARTS-HF study, which is part of the ongoing MOONRAKER study program with finerenone. 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. Finerenone has also been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU, and Japan and these applications are currently under review (see above, vide supra).. Further regulatory applications to health authorities in other markets worldwide will follow.

“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."

See citation- Solomon SD, McMurray JJV et al. Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction. N Engl J Med 2024;391:1475 DOI: 10.1056/NEJMoa2407107.