EMA CHMP recommends Bayer’s finerenone (Kerendia) for heart failure with LVEF ≥40% (HFmrEF/HFpEF), backed by FINEARTS-HF trial data. Approval pending; expands nsMRA options amid unmet needs.
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending finerenone (Kerendia™) for adults with heart failure and left ventricular ejection fraction (LVEF) of at least 40%. This covers patients with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). A final European Commission decision is expected soon.
Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), blocks overactivation of the mineralocorticoid receptor pathway to reduce inflammation, fibrosis, and cardiorenal damage. “Finerenone could become a relevant therapy for this large and growing patient group,” said Christine Roth, Bayer’s Executive Vice President, citing consistent benefits from the Phase III program.
Key Evidence from FINEARTS-HF Trial
The recommendation stems from the Phase III FINEARTS-HF trial (NCT04435626), a large randomized, double-blind, placebo-controlled study in symptomatic heart failure patients with LVEF ≥40%. Finerenone significantly cut the primary endpoint: cardiovascular death and total heart failure events (first and recurrent hospitalizations or urgent visits). Results held across subgroups, including those on SGLT2 inhibitors or with comorbidities.
Findings were presented at ESC Congress 2024 and published in the New England Journal of Medicine.
Broader Approvals and MOONRAKER Program
Kerendia (Firialta™ in some markets) is approved for CKD in type 2 diabetes across 95+ countries, including the US, Europe, Japan, and China. It’s also cleared for HF with LVEF ≥40% in the US and Japan, with more reviews ongoing.
FINEARTS-HF forms part of Bayer’s expansive MOONRAKER Phase III program—covering 15,000+ patients including trials like REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF to expand finerenone’s role in heart failure.
Addressing Unmet Needs in HFmrEF and HFpEF
Heart failure affects 64 million worldwide and 15 million in Europe, driving more hospitalizations in those over 65 than many cancers. Half of cases involve LVEF ≥40% (HFmrEF: 41-49%; HFpEF: ≥50%), often with comorbidities like CKD, hypertension, diabetes, and atrial fibrillation. While HFrEF (LVEF ≤40%) therapies have advanced, HFmrEF and HFpEF lag, creating urgent demand for options like finerenone.
References
Finerenone recommended for the treatment of patients with heart failure with LVEF ≥40% in the EU, 30 January 2026, Finerenone recommended for the treatment of patients with heart failure with LVEF ≥40% in the EU
Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants with Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40% (FINEARTS-HF), ClinicalTrials.gov ID NCT04435626, https://clinicaltrials.gov/study/NCT04435626
Scott D. Solomon et al, Finerenone in Heart Failure with Mildly Reduced or Preserved Ejection Fraction, N Engl J Med 2024;391:1475-1485, https://www.nejm.org/doi/abs/10.1056/NEJMoa2407107