Finerenone Receives FDA Approval for Treatment of Chronic Kidney Disease Associated with Type 2 Diabetes

The FDA has approved finerenone (Kerendia, Bayer) for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Finerenone is a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained estimated glomerular filtration rate decline, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure. It is also the first and only nonsteroidal MRA that has been approved for use in this patient population.

The FDA approval was based on the results from the phase 3 FIDELIO-DKD trial, which demonstrated positive kidney and cardiovascular outcomes in patients with CKD associated with T2D. The approval also follows the previously granted priority review designation by the FDA.

“The patient population included in the trial that supported the approval of Kerendia were at risk of chronic kidney disease progression despite receiving standard of care treatment to control blood pressure and blood glucose,” said lead study investigator George Bakris, MD, University of Chicago, in a press release. “In people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection.”

Currently, many patients with CKD associated with T2D are at risk for CKD progression and the occurrence of cardiovascular events. Known to be a leading cause of end-stage kidney disease, T2D can cause patients to need dialysis or a kidney transplant in order to stay alive. Additionally, Black and Hispanic American patients have been found to have increased rates of kidney failure in comparison to white patients.

“Chronic kidney disease associated with type 2 diabetes can have such a debilitating impact on patients’ lives. Unfortunately, this disease is far reaching, as up to 40% of all patients with type 2 diabetes develop chronic kidney disease,” said kidney transplant patient Kevin Longino, CEO, National Kidney Foundation, in the press release. “It is important for physicians and patients to have new treatment options that can slow chronic kidney disease progression.”

Finerenone has been found to be successful in this patient population because of its ability to block the overactivation of the mineralocorticoid receptor, which is thought to contribute to fibrosis and inflammation. If fibrosis and inflammation occurs, these issues can lead to permanent kidney damage.

“Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist proven to significantly slow chronic kidney disease progression and reduce cardiovascular risk in people with chronic kidney disease associated with type 2 diabetes,” said Amit Sharma, MD, vice president of cardiovascular and renal, Bayer US Medical Affairs, in the press release. “We are excited to bring this new kidney-focused treatment to people living with this condition.”

Currently, finerenone is planned to be available in the United States at the end of July 2021. Additionally, finerenone has been submitted by Bayer for marketing authorization in the European Union.

REFERENCE

Bayer’s KERENDIA® (finerenone) Receives U.S. FDA Approval for Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes. Whippany, NJ: Bayer; July 10, 2021. https://www.businesswire.com/news/home/20210709005441/en. Accessed July 20, 2021.