According to a press release from Bayer, the FDA's action follows a phase 3 study, Fidelio DKD, which has shown that the drug slows or reduces the progression of chronic kidney disease (CKD) in patients with type 2 diabetes. The FDA has prioritized Bayer's drug, a combination of Fidelio and a second drug used to treat kidney failure.

CKD, a progressive disease that can lead to kidney damage and eventual failure without treatment currently available. There is a significant medical need, especially for people with type 2 diabetes and other chronic kidney disease, "FDA Commissioner Scott Gottlieb said in a statement.

We are encouraged that the FDA has prioritized the NDA review as it could accelerate our ability to provide Finerenon to patients. Based on trial data, we offer the potential to delay the progression of CKD while reducing the risk of cardiovascular events.