The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Kerendia® (finerenone), a non-steroidal selective mineralocorticoid receptor antagonist (nsMRA), for the treatment of symptomatic chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40% in adults in the UK. The new indication covers both heart failure phenotypes: heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF).
Dr Fozia Ahmed, Consultant Cardiologist at Manchester University NHS Foundation Trust, said: “Heart failure with preserved ejection fraction and heart failure with mildly reduced ejection fraction are among the most difficult forms of heart failure to manage in routine clinical practice. Options have been limited and few have proven efficacy.The MHRA approval provides clinicians with additional approved options to consider within the current heart failure management pathway.”The UK has a large and historically undertreated population of heart failure patients. ”
Marketing approval in the UK was based on the results of the Phase III FINEARTS-HF trial, which investigated the efficacy and safety of finerenone in preventing cardiovascular death and heart failure events in approximately 6,001 adult patients with symptomatic heart failure (finerenone n=3,003, placebo n=2,998) with LVEF ≥40%. In FINEARTS-HF, finerenone significantly reduced the risk of the composite primary endpoint of cardiovascular death and total (first and recurrent) heart failure events, defined as hospitalization for cardiovascular disease or emergency visit for heart failure, by 16% (relative rate reduction) with an absolute rate reduction of 2.8/100 patient-years, rate ratio (RR) 0.84 (95% CI, 0.74-0.95; p=0,0072), median time It was compared to a placebo in addition to usual care over 32 months. The benefits demonstrated in the primary endpoint were consistent across all prespecified subgroups, regardless of background therapy, comorbidities, or admission status, including ejection fraction. Finerenone was generally well tolerated in this study, which is consistent with finerenone’s well-established safety profile.
Based on the results of FINEARTS-HF, finerenone is the first nonsteroidal MR antagonist to demonstrate a definitive benefit on the primary composite endpoint compared to placebo in a Phase III study in adults with this common form of heart failure.
More than 1 million people in the UK live with heart failure, approximately half of whom have LVEF ≥40%, with HFpEF being the more common phenotype, primarily affecting older, multimorbid patients and placing a significant burden on NHS services. The performance of HFpEF in England remains poor. In a population-wide analysis of electronic medical records, approximately 1 in 3 patients hospitalized with heart failure had HFpEF. During a median follow-up of 11 months, approximately two-thirds were readmitted and nearly half died. Compared with heart failure with reduced ejection fraction (LVEF ≤ 40%, or HFrEF), HFpEF was associated with higher readmission rates and a slightly higher risk of 1-year post-discharge mortality, primarily caused by non-cardiovascular deaths. Overall, heart failure has a poor prognosis, and cohort studies have shown that over 10 years survival rates for heart failure patients are worse than many common cancers (although outcomes vary by cancer type and gender).
Dr Nick Hartshorne-Evans, chief executive and founder of heart failure charity Pumping Marvelous, said: “Heart failure with preserved ejection fraction can have a significant and often misunderstood impact on patients’ lives. Many people living with HFpEF experience persistent shortness of breath, fatigue and repeated hospitalizations, which limit their independence and impact their physical, mental and social health. For patients, the burden of HFpEF is not only clinical, but also shapes their daily lives and places a significant burden on their families and caregivers. There is a clear need for greater awareness of this condition and improved management to help people live better with heart failure.”
Heart failure with LVEF ≥ 40% is a major burden for both patients and the healthcare system, and high hospitalization rates place continued pressure on NHS services. We are pleased that the MHRA has approved Kerendia for this indication. As a next step, we are committed to working with health technology review bodies, the NHS and the clinical community to help ensure timely and fair access for eligible patients who may benefit. ”
Tomer Pfeffer, CEO, Bayer UK&Ireland
The UK marketing authorization follows the recent approval of Kerendia by the European Commission on March 26, 2026, for the treatment of heart failure in adults with LVEF ≥40% in the European Union, and prior approval by the US Food and Drug Administration (FDA) in July 2025 for the same indication. In the UK, Kerendia® (finerenone) (10 mg or 20 mg) is also approved for the treatment of chronic kidney disease associated with type 2 diabetes (stages 3 and 4 with albuminuria) in adults.
