FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Bayer announced that the U.S. Food and Drug Administration (FDA) has approved finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%. Finerenone (10 mg, 20 mg, 40 mg) is now approved to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in this group of patients.

In March, the FDA granted Priority Review to the supplemental New Drug Application for finerenone in this indication. The approval is based on positive results from the Phase III FINEARTS-HF study, presented at ESC Congress 2024 and published in the New England Journal of Medicine.

In the study, finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events, including hospitalizations and urgent visits for heart failure. These benefits were consistent regardless of background therapy, comorbidities, or hospitalization status.

The study is part of the ongoing MOONRAKER program, one of the largest Phase III clinical trial programs in heart failure, involving over 15,000 patients. The program aims to provide a broad understanding of finerenone’s role in heart failure management across different patient groups and clinical settings.

“The FDA’s approval of finerenone expands treatment options for patients with heart failure and LVEF of ≥40%—a large group of patients with poor prognosis,” said Dr. Scott D. Solomon, Professor of Medicine, Harvard Medical School, Director of the Clinical Trials Outcomes Center at Mass General Brigham, and Chair of the study’s Executive Committee. “Based on the FINEARTS-HF study results, finerenone can become part of comprehensive care, improve outcomes, and offer new hope to these patients.”

With this approval, Kerendia is now the only non-steroidal mineralocorticoid receptor antagonist (MRA) approved in the U.S. for both chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and heart failure with LVEF of ≥40%.

Finerenone is the first drug targeting the mineralocorticoid receptor pathway to show cardiovascular benefits in this patient population in a Phase III study. By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key factors in heart failure with LVEF ≥40%, including hemodynamic, inflammatory, and fibrotic processes.

“Today’s approval of finerenone in heart failure with LVEF of ≥40% marks an important step in Bayer’s efforts to improve care for these patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “Patients with this condition often have other health problems such as hypertension and atrial fibrillation, and physicians have had limited treatment options. In the FINEARTS-HF study, finerenone reduced cardiovascular events, and we are optimistic about its potential to become a core therapy for this group.”