WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayertoday announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of the investigational drug finerenone, for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Finerenone is a potential first-in-class investigational non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that demonstrated positive kidney and cardiovascular outcomes in patients with CKD and T2D in the Phase III FIDELIO-DKD study.^1,2,3

“As the prevalence of type 2 diabetes continues to rise, approximately 40% of individuals with type 2 diabetes are at risk of developing chronic kidney disease,⁴ which has become a serious global health challenge that needs to be addressed,” said Joerg Moeller, M.D., member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “The findings from the FIDELIO-DKD study demonstrated the potential role of finerenone in improving outcomes in these patients by delaying CKD progression and reducing the risk for cardiovascular events.^1,2 Those findings have informed these regulatory submissions, which are an important step towards providing finerenone as a potential new treatment option for these patient populations.”

The MAA submitted to the EMA, and the NDA submitted to the U.S. FDA seek approval of the investigational drug finerenone, which was studied when added to the standard of care for the treatment of CKD in individuals with T2D. Both regulatory applications are based on positive data from the FIDELIO-DKD study, which is part of the largest Phase III clinical trial program to date in CKD and T2D.^1,2 Results from the trial were presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020, and simultaneously published in the October 23, 2020 edition of the New England Journal of Medicine.

About Finerenone

Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that has been shown to reduce many of the harmful effects of mineralocorticoid receptor (MR) overactivation.⁵ Mineralocorticoid receptor overactivation is a driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.^6,7

The Phase III program with finerenone in CKD and T2D randomized 13,000 patients across a broad range of disease severity including those with early kidney damage and more advanced stages of kidney disease. It is the largest Phase III clinical trial program to date in CKD and T2D and comprises two studies, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes.^1,2

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III study that investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D from more than 1,000 sites across 48 countries worldwide. Finerenone 10 mg or 20 mg orally once daily when added to standard of care, including blood glucose lowering therapies and maximum tolerated dose of RAS-blocking therapy such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), significantly reduced the combined risk of time to kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40 percent from baseline over a period of at least four weeks, or renal death by 18 percent (HR 0.82 [95% CI, 0.73-0.93; p=0.0014]) over a median duration of follow-up of 2.6 years.

FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) is still ongoing and is investigating the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of cardiovascular morbidity and mortality in approximately 7,400 patients with CKD and T2D across 47 countries including sites in Europe, Japan, China and the U.S.

Bayer also recently announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III study which will investigate finerenone compared to placebo in more than 5,500 symptomatic heart failure patients (New York Heart Association class II-IV) with a left ventricular ejection fraction of ≥40 percent. The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) events (defined as hospitalizations for HF or urgent HF visits).

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. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.us.

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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.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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¹ Data on file.
² Bakris, GL., et al. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Oct 23. DOI: 10.1056/NEJMoa2025845.
³ Agarwal, R, et al. Steroidal and non-steroidal mineralocorticoid receptor antagonists in cardiorenal medicine. Eur Heart J. 2020;00:1-12.
⁴ Bailey, R, et al.. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes. 2014;7:415.
⁵ Kolkhof, P, et al. Steroidal and novel non-steroidal mineralocorticoid receptor antagonists in heart failure and cardiorenal diseases: comparison at bench and bedside. Handb Exp Pharmacol. 2017;243:271-305.
⁶ Bauersachs J, et al. Mineralocorticoid receptor activation and mineralocorticoid receptor antagonist treatment in cardiac and renal diseases. Hypertension. 2015 Feb;65(2):257-63.
⁷ Buonafine, M, et al. Mineralocorticoid Receptor and Cardiovascular Disease. Am J Hypertens. 2018;31(11):1165-1174.

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