U.S. FDA grants Priority Review to New Drug Application for finerenone to treat patients with chronic kidney disease and type 2 diabetes

Submission to FDA was based on positive data from Phase III FIDELIO-DKD study recently published in the New England Journal of Medicine

WHIPPANY, NJ, USA I January 12, 2021 I Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This regulatory submission was based on Phase III FIDELIO-DKD trial data, which were recently 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.

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

“There is currently a significant unmet medical need for the nearly 40 percent of people in the U.S. living with type 2 diabetes who will develop chronic kidney disease. This progressive condition can lead to kidney damage and eventual failure, despite currently available treatments,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer. “Based on study data, finerenone offers a potential new strategy to delay CKD progression, while reducing the risk of cardiovascular events. We’re encouraged that the FDA has granted the NDA a Priority Review, as it potentially expedites our ability to make finerenone available to patients.”

The FDA grants Priority Review to medicines that may offer significant improvements in the treatment, diagnosis or prevention of a serious condition. Under a Priority Review designation, the agency’s goal is to take action on a New Drug Application within six months of acceptance, compared to 10 months under standard review.

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

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.

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.

SOURCE: Bayer

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