Bayer gets USFDA Priority Review for finerenone for type 2 diabetes, CKD
Whippany: Bayer has recently announced that the U.S. Food and Drug Administration (USFDA) 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.
"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.
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. 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.