Bayer receives MHRA approval for Kerendia®▼(finerenone) in adults with heart failure with LVEF ≥40%

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.¹ 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 hospitalisation and mortality. In particular, until recently, treatment options for heart failure with preserved ejection fraction have been limited with few proven benefits.⁶ 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 authorisation 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 hospitalisations 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.² The benefits shown in the primary endpoint were consistent across all pre-specified subgroups, regardless of background therapy, comorbidities, or hospitalisation status, including ejection fraction.² Finerenone was generally tolerated in the study, which is consistent with the well-established safety profile of finerenone.²

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.²

More than one million people in the UK are living with heart failure,³ 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.⁴ Outcomes for HFpEF in England remain poor. In population-wide linked electronic health record analyses, around one in three patients hospitalised with heart

failure had HFpEF.⁷ During a median follow-up of 11 months, around two-thirds were re-hospitalised and nearly half died.⁷ Compared with heart failure with reduced ejection fraction (LVEF ≤40%, or HFrEF), HFpEF was associated with higher rates of rehospitalisation and a modestly higher risk of 1-year mortality after discharge, driven predominantly by non-cardiovascular deaths.⁸ 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).⁵

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 hospitalisation rates placing ongoing pressure on NHS services,” said Tomer Feffer, CEO Bayer UK&Ireland. “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.”

The UK marketing authorisation 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,⁹ and prior approval by the U.S. Food and Drug Administration (FDA) in July 2025 for the same indication.¹⁰ In the UK, Kerendia®▼(finerenone) (10mg or 20mg) is also approved for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.¹¹

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About FINEARTS-HF

FINEARTS-HF is a randomised, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of Kerendia® (finerenone) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomisation. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalisations for HF or urgent HF visits.

Around 6,001 patients were randomised from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

The FINEARTS-HF results were presented at European Society of Cardiology Congress 2024 and simultaneously published in the New England Journal of Medicine. The study is part of the ongoing MOONRAKER programme, one of the largest Phase III clinical trial programmes 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.

About Kerendia® (finerenone)

Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation.^12-15 MR overactivation

contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.^15-17

The study programme with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programmes in HF and CKD respectively. The MOONRAKER programme includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The THUNDERBALL CKD programme consists of the completed studies FIDELIO-DKD and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA, FIONA-OLE, FINE-ONE, and Phase II study CONFIDENCE.

About Heart Failure

Heart failure is a complex clinical syndrome, characterised by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen.¹⁸ HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation.¹⁹ Symptoms of HF may include shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.²⁰ Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease.¹⁹

When categorised by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:²¹

· Heart failure with reduced ejection fraction (HFrEF) is characterised by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%²¹

· Heart failure with mildly reduced ejection fraction (HFmrEF) is a category for patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump²²

· Heart failure with preserved ejection fraction (HFpEF) is a condition characterised by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%²¹

While HFrEF (LVEF ≤40%) and the combined HFmrEF/HFpEF phenotypes (LVEF ≥40%) each account for approximately half of all HF cases, the burden of cardiovascular and non-cardiovascular comorbidities is greater in patients with LVEF ≥40%.¹⁹

Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalised with HF.¹⁹ While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%.⁶

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritises targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.co.uk.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References:

1. UK Summary of Product Characteristics (SmPC) for Kerendia®▼(finerenone) 10mg, 20mg, 40mg film-coated tablets.

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PP-KER-GB-0914 / April 2026