Bayer's big news: Finerenone gains FDA approval for patients with chronic kidney disease, type 2 diabetes

The FDA has approved finerenone for slowing the progression of chronic kidney disease (CKD) in patients with type 2 diabetes (T2D).

The mineralocorticoid receptor antagonist, sold by Bayer under the name Kerendia, is also indicated to help patients with T2D-related CKD reduce the risk of kidney failure, heart failure hospitalization and cardiovascular death.

The FDA’s decision was based largely on results from the FIDELIO-DKD trial, which found that finerenone reduces the risk of cardiovascular complications and reduces the risk of new-onset atrial fibrillation in patients with T2D and CKD.

“The patient population included in the trial that supported the approval of Kerendia were at risk of CKD progression despite receiving standard of care treatment to control blood pressure and blood glucose,” George Bakris, MD, a professor of medicine at the University of Chicago and lead investigator of the FIDELIO-DKD trial, said in a prepared statement. “In people with CKD associated with T2D, physicians now have a new treatment to provide kidney protection.”

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