FDA grants priority review to diabetic kidney disease treatment from Bayer
The FDA has granted priority review to a new drug application for finerenone, a non-steroidal mineralocorticoid receptor inhibitor antagonist, for the treatment of diabetic kidney disease.
According to a press release from Bayer, the action by the FDA follows results from phase 3 of the FIDELIO-DKD study, which demonstrated the drug was effective for delaying the progression of chronic kidney disease and reducing the risk for cardiovascular events in patients with type 2 diabetes.
Healio Nephrology reported on the findings as part of its coverage of the American Society of Nephrology’s Kidney Week, which was held virtually in October 2020. The story, which contains more specifics on the study, can be found here.
“There is currently a significant unmet medical need for the nearly 40 [%] of people in the U.S. living with type 2 diabetes who will develop chronic kidney disease,” Michael Devoy, head of medical affairs and pharmacovigilance of Bayer AG’s pharmaceuticals division and chief medical officer for the company, said in the release. “This progressive condition can lead to kidney damage and eventual failure, despite currently available treatments. 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 [new drug application] NDA a priority review, as it potentially expedites our ability to make finerenone available to patients.”