Bayer gets USFDA nod for Finerenone for new indication in heart failure patients

In March, the FDA granted Priority Review designation for the supplemental New Drug Application for finerenone for the treatment of adult patients with HF with an LVEF of ≥40%. The approval of finerenone by the FDA is based on the positive results of the pivotal Phase III FINEARTS-HF study, the results of which were presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine. In FINEARTS-HF, finerenone achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. These benefits were demonstrated 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 to date in heart failure, including over 15,000 patients, which aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – a large and growing group of patients with a poor prognosis,” said Scott D. Solomon, MD, Professor of Medicine, Harvard Medical School, Director, Clinical Trials Outcomes Center, Mass General Brigham, and Chair of the study’s Executive Committee. “Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care, improve clinical outcomes and offer new hope to these patients in the U.S. with persistent high unmet medical needs.”

With this FDA approval, Kerendia is a non-steroidal mineralocorticoid receptor (MR) antagonist approved in the U.S. for chronic kidney disease (CKD) associated with T2D and for HF with LVEF of ≥40%. Finerenone is a non-steroidal, selective MRA (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 a 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.

“Building on our longstanding expertise in bringing innovative science to the cardiovascular space, today’s approval of finerenone in heart failure with a left ventricular ejection fraction of ≥40% marks an important milestone in Bayer’s commitment to improving the lives of patients with this condition. While often balancing multiple comorbidities such as hypertension and atrial fibrillation, physicians have faced limited proven treatment options for these complex patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “In the FINEARTS-HF study, finerenone reduced the occurrence of cardiovascular events in patients with this common form of heart failure, and we are excited about the potential of finerenone to emerge as a foundational therapy that can contribute to addressing patients’ tremendous needs.”

Approximately 3.7 million Americans live with HF LVEF ≥40%, which accounts for more than 500,000 hospitalizations per year. Most are balancing multiple comorbidities, such as diabetes, hypertension, obesity, and CKD, and they face high rates of hospitalization, leading to considerable mortality risk and significant strain on healthcare systems. In patients with HF LVEF ≥40%, 25% are rehospitalized due to HF within 1 year of discharge, and the 5-year mortality rate is 75%.

Finerenone is not currently approved in HF with an LVEF of ≥40% outside of the U.S. Finerenone has 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. Further regulatory applications to health authorities in other markets worldwide have been filed or will follow.

Since 2021, Kerendia (finerenone, 10 mg or 20 mg) is approved in the U.S. for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure. Based on the data from the FIDELIO-DKD and FIGARO-DKD trials, finerenone is approved for the treatment of adult patients with CKD associated with T2D in more than 95 countries worldwide, including in China, Europe, Japan, and the U.S., and recommended across multiple international guidelines as a pillar of therapy for improved kidney and cardiovascular outcomes in patients with CKD associated with T2D.