FDA Approves Kerendia for Patients With CKD Associated With T2D

Positive drug trial results suggest promising outcomes for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

The FDA has approved finerenone (Kerendia), a nonsteroidal mineralocorticoid receptor antagonist for treatment of patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). The approval follows a priority review designation of the drug.

The drug is the only one shown to reduce the risk of sustained estimated glomerular filtration rate decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D.

The approval comes in response to demonstrated positive kidney and cardiovascular outcomes in patients with CKD and T2D in the phase 3 FIDELIO-DKD trial. Data regarding the trial were published in the New England Journal of Medicine in October 2020.

“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, University of Chicago and lead FIDELIO-DKD study investigator, said in a statement announcing the approval. “In people with CKD associated with T2D, physicians now have a new treatment to provide kidney protection.”

Kerendia inhibits overactivation of the mineralocorticoid receptor (MR), a process that is thought to cause fibrosis and inflammation and subsequently contribute to permanent structural kidney damage. The drug works to slow CKD progression and reduce the risk of kidney failure, heart attack, heart failure–related hospitalization, or cardiovascular death in patients with CKD associated with T2D.

T2D is the leading contributor to end-stage kidney disease, and as many as 40% of all patients with T2D develop CKD. Despite guideline-directed therapies, many patients with CKD associated with T2D are at high risk of cardiovascular disease and CKD progression, which can sometimes lead to kidney failure. Defective filtering of the kidney can contribute to issues regarding fluid, electrolytes, and waste build-up in the body.

Black and Hispanic Americans are more at risk of kidney failure than non-Hispanic and White Americans.

“Chronic kidney disease associated with T2D can have such a debilitating impact on patients’ lives. Unfortunately, this disease is far reaching, as up to 40% of all patients with T2D develop CKD,” Kevin Longino, CEO, National Kidney Foundation, and a kidney transplant patient, said in the statement. “It is important for physicians and patients to have new treatment options that can slow chronic kidney disease progression.”

Kerendia is expected to be available in the United States as soon as the end of July 2021. Finerenone is pending marketing authorization in the European Union.

When taking Kerendia, patients might experience adverse effects that include hyperkalemia, hypotension, or hyponatremia. Patients with adrenal insufficiency and those concomitantly using strong cytochrome P450 3A4 inhibitors are advised not to take Kerendia.

Reference

FDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes. News release. FDA; July 9, 2021. Accessed July 14, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease.