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MHRA Approves Finerenone for Symptomatic Chronic Heart Failure with LVEF ≥40% in UK

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MHRA Approves New Heart Failure Treatment, Finerenone (Kerendia®)

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for finerenone (marketed as Kerendia®) for the treatment of symptomatic chronic heart failure in adults with a left ventricular ejection fraction (LVEF) of 40% or greater. The approval covers both heart failure with mildly reduced ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF).

Regulatory Decision and Clinical Basis

The approval is based on data from the Phase III FINEARTS-HF clinical trial.

Key Trial Details:

  • Study Population: Approximately 6,001 adult patients with symptomatic chronic heart failure and an LVEF ≥40%.
  • Primary Endpoint: A composite of cardiovascular death and total heart failure events (hospitalizations or urgent visits).
  • Follow-up: Median of 32 months.

Results:

  • Relative Risk Reduction: Treatment with finerenone demonstrated a 16% relative rate reduction in the risk of the primary composite endpoint compared to placebo.
  • Statistical Data: The absolute rate reduction was 2.8 events per 100 patient-years, with a rate ratio of 0.84 (95% confidence interval: 0.74-0.95; p=0.0072).
  • Consistency: The reported benefits were consistent across pre-specified patient subgroups. The safety profile was reported as consistent with finerenone's established profile.

Condition Context and Epidemiology

  • Prevalence: More than one million people in the UK live with heart failure. An estimated half of these have heart failure with an LVEF ≥40%, with HFpEF being the more prevalent phenotype.
  • Patient Profile: HFpEF predominantly affects older patients with multiple coexisting health conditions.
  • Outcomes Data: Population-wide analyses in England indicate approximately one in three patients hospitalized with heart failure had HFpEF. During a median follow-up of 11 months, around two-thirds of HFpEF patients were re-hospitalized and nearly half died.

Drug Profile and Other Approvals

  • Drug Class: Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA).
  • Significance: Based on the FINEARTS-HF results, finerenone is described as the first non-steroidal mineralocorticoid receptor antagonist to demonstrate a benefit for its primary composite endpoint versus placebo in a Phase III study for this form of heart failure.
  • Existing UK Approval: Finerenone was previously approved in the UK for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
  • International Status: The MHRA's decision follows recent approvals for the same indication by the European Commission (March 2026) and the U.S. Food and Drug Administration (July 2025).

Reaction and Next Steps

"HFpEF and HFmrEF remain challenging to manage in clinical practice and affect a substantial proportion of patients."
– Dr. Fozia Ahmed, Consultant Cardiologist, Manchester University NHS Foundation Trust

Dr. Ahmed noted that treatment options for HFpEF have been limited and described the MHRA approval as providing clinicians with an additional licensed treatment option.

"HFpEF can have a significant impact on patients' lives, with symptoms including breathlessness, fatigue, and repeated hospital admissions."
– Dr. Nick Hartshorne-Evans, Chief Executive, Pumping Marvellous, The Heart Failure Charity

Dr. Hartshorne-Evans highlighted the need for greater recognition and improved management of the condition.

Tomer Feffer, CEO of Bayer UK&Ireland, stated that heart failure with LVEF ≥40% represents a substantial burden and that the company is committed to working with health technology assessment bodies, the NHS, and clinicians to support access for eligible patients.