13 January 2021 - - The US Food and Drug Administration has accepted German healthcare company Bayer's (OTC: BAYZF) New Drug Application and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease and type 2 diabetes, the company said.

This regulatory submission was based on Phase III FIDELIO-DKD trial data, which were recently presented at the American Society of Nephrology's 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 that demonstrated positive kidney and cardiovascular outcomes in patients with CKD and T2D in the Phase III FIDELIO-DKD study.

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.

Finerenone (BAY 94-8862) is an investigational, non-steroidal, selective mineralocorticoid receptor antagonist that has been shown to reduce many of the harmful effects of mineralocorticoid receptor overactivation.

Mineralocorticoid receptor overactivation is a driver of kidney and cardiovascular damage through inflammatory and fibrotic processes.

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.

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.