The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for 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 the heart failure phenotypes of 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 remain among the most challenging forms of heart failure to manage in everyday clinical practice. They affect a substantial large proportion of patients seen across the NHS and are associated with high rates of hospitaliZation and mortality. In particular, until recently, treatment options for heart failure with preserved ejection fraction have been limited with few proven benefits. The MHRA approval provides clinicians with an additional licensed option to consider within current heart failure management pathways for a large and historically underserved heart failure patient population in the UK.”
The marketing authorization in the UK is based on results from the Phase III FINEARTS-HF study, investigating the efficacy and safety of finerenone for the prevention of cardiovascular death and heart failure events in approximately 6,001 adult patients (finerenone n=3,003; placebo n=2,998) with symptomatic heart failure and an LVEF ≥ 40 %. In FINEARTS-HF, finerenone significantly reduced the risk of the composite primary endpoint of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits, by 16 % (relative rate reduction) absolute rate reduction 2.8 per 100 patient years, rate ratio (RR) 0.84 [95 % CI, 0.74-0.95; p=0,0072] over a median duration of 32 months, versus placebo in addition to usual therapy. The benefits shown in the primary endpoint were consistent across all pre-specified subgroups, regardless of background therapy, comorbidities, or hospitalization status, including ejection fraction. Finerenone was generally tolerated in the study, which is consistent with the well-established safety profile of finerenone.
Based on the results of FINEARTS-HF, finerenone is the first non-steroidal MR antagonist to demonstrate definitive benefits in its primary composite endpoint versus placebo in a Phase III study in adults with this common form of heart failure.
More than one million people in the UK are living with heart failure, around half of whom have heart failure with an LVEF ≥ 40 %, with HFpEF being the more prevalent phenotype, predominately affecting older, multimorbid patients and placing significant strain on NHS services. Outcomes for HFpEF in England remain poor. In population-wide linked electronic health record analyzes, around one in three patients hospitalized with heart failure had HFpEF. During a median follow-up of 11 months, around two-thirds were re-hospitalized and nearly half died. Compared with heart failure with reduced ejection fraction (LVEF ≤ 40 %, or HFrEF), HFpEF was associated with higher rates of rehospitalization and a modestly higher risk of 1-year mortality after discharge, driven predominantly by non-cardiovascular deaths. Overall, heart failure carries a poor prognosis, with a cohort study showing that survival in people with heart failure over 10-year was worse than that seen for many common cancers (although outcomes varied by cancer type and sex).
Dr Nick Hartshorne-Evans, Chief Executive and Founder of Pumping Marvellous, The Heart Failure Charity, said: “Heart failure with preserved ejection fraction can have a profound and often misunderstood impact on patients’ lives. Many people living with HFpEF experience persistent breathlessness, fatigue and repeated hospital admissions, which can limit independence and affect physical, emotional and social wellbeing. For patients, the burden of HFpEF is not just clinical - it shapes everyday life and places considerable strain on families and carers. There is a clear need for greater recognition of this condition and improved management that can help people live better with heart failure.”
Heart failure with LVEF ≥ 40 % represents a substantial burden for both patients and the health system, with high hospitalization rates placing ongoing pressure on NHS services, We are pleased that the MHRA has approved Kerendia in this indication. As a next step, we are committed to working with health technology assessment bodies, the NHS and the clinical community to support timely and equitable access for eligible patients who may benefit.”
Tomer Feffer, CEO, Bayer UK&Ireland
The UK marketing authorization follows recent approval of Kerendia by the European Commission on 26th March 2026 for the treatment of adults with heart failure with LVEF ≥ 40 % in the European Union, and prior approval by the U.S. 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 (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.