Bayer has received the US Food and Drug Administration (FDA) approval for finerenone to treat heart failure in adults with a left ventricular ejection fraction (LVEF) of 40% or more.
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist, validated for managing chronic kidney disease associated with type 2 diabetes.
Marketed as Kerendia in the US and Firialta in other territories, finerenone is designed to reduce the risk of cardiovascular death, heart failure hospitalisations, and urgent visits.
The drug works by blocking the adverse effects of mineralocorticoid receptor overactivation, which contributes to chronic kidney disease progression and cardiovascular damage.
It is the only non-steroidal mineralocorticoid receptor antagonist approved in the US for both chronic kidney disease with type 2 diabetes and heart failure with LVEF of ≥40%.
Bayer global product strategy and commercialisation executive vice president Christine Roth said: “Today’s approval of finerenone in heart failure with a left ventricular ejection fraction of 40% or more 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.
“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.”
The FDA’s decision follows the positive results from the Phase 3 FINEARTS-HF study, which demonstrated a significant reduction in cardiovascular death and heart failure events.
The clinical trial is part of the MOONRAKER programme, one of the largest Phase 3 clinical trial programmes in heart failure.
In the study, the drug was shown to target the mineralocorticoid receptor and renin-angiotensin-aldosterone system overactivation.
Also, it addressed the key aspects of heart failure, including hemodynamic and inflammatory processes.
Finerenone is not yet approved for heart failure with LVEF of 40% or more outside the US.
Bayer’s marketing authorisation applications for the drug are under review in China, the European Union (EU), and Japan, with plans for further submissions in other markets.
The study’s executive committee chair Scott Solomon said: “The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of 40% or more – a large and growing group of patients with a poor prognosis.
“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 US with persistent high unmet medical needs.”
Recently, Bayer received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval for elinzanetant, marketed as Lynkuet.
