Reading, UK, 1st September, 2024 – Detailed results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone (Kerendia®) showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%.1 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.1 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.1 The FINEARTS-HF findings were presented today during a Hot Line session at ESC Congress 2024 and simultaneously published in the New England Journal of Medicine.
“Treating heart failure patients with LVEF ≥ 40% has provided a significant challenge for many physicians, and there is a high unmet medical need as these patients have a substantial risk for serious cardiovascular events. Unlike heart failure with reduced ejection fraction, where many treatments are now available, for heart failure with LVEF ≥ 40%, we currently have limited treatment options with proven efficacy,” said Scott D. Solomon, MD, The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Senior Physician at Brigham and Women’s Hospital and Chair of the study’s Executive Committee. “With FINEARTS-HF as the first large-scale study of a non-steroidal, selective mineralocorticoid receptor antagonist in these underserved heart failure patients, finerenone, if approved, may have the potential to help these vulnerable patients.”
The benefits shown in the primary endpoint were consistent across all prespecified subgroups, regardless of background therapy, comorbidities, or hospitalisation status, including those based on disease state (ejection fraction) or baseline use of SGLT2-inhibitors. Finerenone also significantly reduced the secondary endpoints of total HF events (RR 0.82 [95% CI, 0.71-0.94; p=0.0062]) and improved patient-reported health status as measured by the change from baseline in Total Symptom Score of Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) (between-group difference 1.6 points [95% CI, 0.8-2.3; p<0.0001]) compared to the placebo group.
Heart failure (HF) affects over 60 million people worldwide;4 approximately half of these patients suffer from HF with a LVEF of ≥40%.5HF with a LVEF ≥40% is associated with multimorbidity, making the condition complex to manage.2 Time trends suggest this growing population will soon account for the majority of patients hospitalised with HF.2 Patients with HF LVEF ≥40% have similar hospitalisation and mortality rates as those with HF LVEF ≤40% (HF with reduced ejection fraction, HFrEF).2 More than half of patients with HF LVEF ≥40% will die within 5 years.2 The high residual risk of CV events and mortality remains high despite available treatments in patients with HF LVEF ≥40%.2
“Bayer has a strong heritage in cardiology, and heart failure is a key focus area for us, with these promising results underpinning our ongoing commitment to patients with this devastating condition. In FINEARTS-HF, finerenone reduced cardiovascular outcomes in a complex to treat patient population. This confirms the potential of finerenone, if approved, as a valuable treatment option in heart failure with mildly reduced or preserved ejection fraction irrespective of background therapy and disease state,” said Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division. “FINEARTS-HF included a high percentage of hospitalised or recently hospitalised patients, which means the results are highly relevant for improving cardiovascular outcomes for patients who do not have enough options.”
Finerenone was well-tolerated in the FINEARTS-HF study, which is consistent with the well-established safety profile of finerenone. The overall incidence of treatment-emergent serious adverse events was comparable between finerenone and placebo groups. Investigator-reported hyperkalaemia-related adverse events occurred more frequently with finerenone than placebo group (9.7 % and 4.2%, respectively). There were no fatal adverse events of hyperkalemia in either treatment group, and hospitalisation or discontinuation due to hyperkalaemia was rare. The occurrence of increased potassium and creatinine levels was also more frequent in the finerenone group compared to the placebo group, but the incidence of potassium above 6.0 mmol/L was generally low.1
Bayer plans to submit applications for marketing authorisation for finerenone for an indication in adults with heart failure and an LVEF of ≥40% to health authorities in due course.
ENDS
Bayer media contact :
Veronica Yao, +44 (0) 7870 485 926
Email: veronica.yao@bayer.com
Notes to Editors
About FINEARTS-HF
FINEARTS-HF is a randomised, double-blind, placebo-controlled, multicentre, event-driven Phase III study investigating the efficacy and safety profile of finerenone for the prevention of cardiovascular death and heart failure (HF) events in adult 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 6,000 patients were randomised from more than 630 sites across 37 countries worldwide to receive either finerenone (n=3,003) or placebo (n=2,998) once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.6
Finerenone once daily, when compared to placebo, significantly reduced the combined risk 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. The results for the individual components of the primary endpoint are: cardiovascular death: RR 0.84 [95% CI, (0.74-0.95; p=0.0072]); total (first and recurrent) HF events, defined as hospitalisations for HF or urgent HF visits: RR 0.82 [95% CI, 0.71-0.94; p=0.0062]). Finerenone also significantly reduced the secondary endpoint of improved patient-reported health status as measured by the change from baseline in Total Symptom Score of Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) (between-group difference 1.6 points [95% CI, 0.8-2.3; p<0.0001]). There was no difference in the finerenone and placebo groups for NYHA class from baseline to 12 months (odds ratio (OR) 1.01 [95% CI, 0.88-1.15]; the composite kidney outcome (HR 1.33; [95% CI, 0.94–1.89]), or all-cause mortality (HR 0.93; [95% CI, 0.83–1.06]).
With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial programme with finerenone, including FINEARTS-HF, is one of the largest HF study programmes to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.7
About Finerenone (Kerendia®▼)
Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation.8-11 MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.12-14
In the UK, finerenone (10mg and 20mg) is approved under the brand name Kerendia® for treating chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. It is recommended by NICE (TA877) as an add-on to optimised standard care, which should include, unless they are unsuitable, the highest tolerated licensed doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and sodium–glucose cotransporter-2 (SGLT2) inhibitors, for people who have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 or more.15
Finerenone has not been approved for the treatment of heart failure by any health authority for use in any country.
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 the Phase II study CONFIDENCE.
▼ 'This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See https://yellowcard.mhra.gov.uk/ for how to report side effects.'
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.16 HF affects more than 60 million people worldwide and is the leading cause of hospitalisation in people over 65.4,2 Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population.2 Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers.17 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.2 Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing.18
Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease.2 Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.4
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:19
- 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%19
- 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 pump4
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%19
While HFrEF (LVEF ≤40%) and HFpEF (LVEF ≥40%) each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%.2 Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalised with HF.2 While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited treatment options for HF with LVEF ≥40%.3
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 prioritizes 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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items 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:
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