Finerenone recommended by CHMP for the treatment of patients with heart failure with LVEF ≥40% in the EU – Bayer

Bayer announced that the CHMP of the  EMA has adopted a positive opinion recommending finerenone (Kerendia), a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF). The final decision by the European Commission is expected over the course of the next few weeks.

“The positive CHMP opinion for finerenone in heart failure with mildly reduced or preserved LVEF marks a significant step forward in addressing the high cardiovascular risks of this large and growing group of patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Based on the pivotal FINEARTS-HF study where finerenone showed early, consistent and sustained efficacy across a range of patient profiles and in addition to usual care, we are confident about the potential of finerenone to become a relevant therapy for these patients.”

The CHMP recommendation is based on the positive results from the pivotal Phase III FINEARTS-HF study, which showed that finerenone significantly reduced the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure events, defined as hospitalizations for HF or urgent HF visits, versus placebo in addition to usual therapy. The benefits of finerenone shown in the primary endpoint were consistent regardless of background therapy, comorbidities, or hospitalization status, including patient subgroups based on ejection fraction or baseline use of SGLT2is. The FINEARTS-HF results were presented at ESC Congress 2024, and simultaneously published in the New England Journal of Medicine . 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.

See 1st 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/NEJMoa240710.