Bayer Seeks Japan Approval for Finerenone to Treat Chronic Heart Failure

Bayer announced the submission of a marketing authorization application to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, seeking approval of finerenone in adult patients with chronic heart failure (with a left ventricular ejection fraction (LVEF) of =40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF)).

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF with a left ventricular ejection fraction (LVEF) of =40% in a phase III study (FINEARTS-HF). Finerenone is already marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the US.

“According to estimates, 1.2 million people in Japan are living with heart failure, and 60% of these patients suffer from heart failure with an LVEF of =40%, who have a multitude of comorbidities such as hypertension and atrial fibrillation, and a high risk for cardiovascular events, providing a significant challenge for their treating physicians,” said Christine Roth, executive vice president, global product strategy and commercialization and member of the pharmaceuticals leadership team at Bayer. “As physicians navigate the complexities of multiple comorbidities, at the same time they are facing a lack of proven treatment options, limiting their ability to help these patients. Finerenone, if approved, has the potential to become a new pillar of treatment for this common form of heart failure, alleviating the burden of serious outcomes in an underserved patient population.”

Heart failure (HF) is a rapidly growing public health issue affecting over 60 million people worldwide. It is the leading cause of hospitalization in people over 65. An estimated 1.2 million people in Japan are affected. As the population ages, the number of patients with HF in Japan continues to increase and is estimated to exceed 1.3 million by 2030. Approximately 60% of these patients suffer from HF with a LVEF of =40%, which is associated with multiple comorbidities, making the condition complex to manage.

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF =40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of =40%.

The submission of finerenone to the MHLW is based on positive data from the phase III FINEARTS-HF study, which is part of MOONRAKER, one of the largest phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings. Finerenone has also been submitted for marketing authorization in this common form of heart failure in China, the EU, and the US, and these applications are currently under review. Further regulatory applications to health authorities in other markets worldwide will follow.

FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven phase III study investigating the efficacy and safety of finerenone (Kerendia) 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 randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.

Around 6,000 patients were randomized 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.

With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program 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.

Kerendia and Firialta are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, as well as inflammatory and fibrotic factors.

Finerenone is marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the US Finerenone is currently not approved for the treatment of heart failure.

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs 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.

Heart failure is a complex clinical syndrome, characterized 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. HF affects more than 60 million people worldwide and is the leading cause of hospitalization in people over 65. Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the ageing population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. 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. 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.

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

When categorized 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:

Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is =40%
Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump
Heart failure with preserved ejection fraction (HFpEF) is a condition characterized 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%
While LVEF =40% and 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%. Time trends also suggest that LVEF =40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF =40%, there are limited treatment options for HF with LVEF =40%.

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.

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