Bayer announced that the FDA has granted it priority review of a new research drug for the treatment of diabetic nephropathy

On January 12, Bayer announced that the FDA had accepted its application for a new drug (NDA) and granted the research drug finerenone priority review for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
previously, Finerenone had been granted fast-track status by the FDA.
review is based on phase 3 clinical trial data called FIDELIO-DKD, which was published in the New England Journal of Medicine.
study showed that finerenone had significant kidney and cardiovascular benefits for people with type 2 diabetes who combined chronic kidney disease, and that finerenone slowed kidney disease progression by 18 percent over a medium 2.6-year period compared to current standard treatments.
Finerenone (BAY94-8862) is a potential "first-in-class" nonsteroidal selective salt corticosteroid litagonist (MRA) that reduces the harmful effects of overactivation of salt corticosteroids.
in the FIDELIO-DKD study showed positive kidney and cardiovascular outcomes in patients with chronic kidney disease and type 2 diabetes.
is one of the most common complications of diabetes and an independent risk factor for cardiovascular disease.
as the disease progresses, more than a-half of people with diabetes will eventually develop chronic kidney disease and even develop kidney failure.
type 2 diabetes is the main cause of end-stage kidney disease and kidney failure, and late-stage patients may need dialysis or kidney transplants to survive.
known to trigger harmful processes such as inflammation and fibrosis in the patient's kidneys and heart by overactivated salt corticosteroids. "
40 percent of people with type 2 diabetes in the U.S. will develop chronic kidney disease, and their medical needs are not being met," said Dr. Michael Devoy, director of medical affairs and drug alerting at Bayer's prescription drug division.
that although treatments are currently available, this resexual disease can lead to kidney damage and eventual failure.
based on research data, finerenone offers a potentially new strategy to delay the progression of chronic kidney disease while reducing the risk of cardiovascular events.
we are encouraged that the FDA has granted priority review eligibility for this new drug to market, which may accelerate our ability to provide refinone to patients.
: This article is intended to introduce advances in medical and health research, not to recommend treatment options.
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: s1. Bayer Announces U.S. FDA Accepts New Drug Application and Grants Priority Review for Investigational Drug Finerenone for Patients with Chronic Kidney Disease and Type 2 Diabetes. Retrieved 2021-01-12, from