The first nonsteroidal mineralocorticoid receptor antagonist to be approved for adults with T2D-associated CKD fills a significant treatment void for millions of patients.
Finerenone, a first-in-class nonsteroidal mineralocorticoid receptor antagonist, was approved on July 9, 2021, by the US Food and Drug Administration (FDA) for treatment of adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Based on results from the pivotal phase 3 FIDELIO-DKD trial, FDA’s approved indication for finerenone is to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular (CV) death, non-fatal myocardial infarction and hospitalization for heart failure in adults with T2D-associated CKD. FIDELIO-DKD results were published in The New England Journal of Medicine in October 2020. The FDA had granted the Bayer New Drug Application priority review in January 2021.
“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 George Bakris, MD, University of Chicago and lead FIDELIO-DKD study investigator in a Bayer press statement. “In people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection.”
FIDELIO-DKD was a randomized, double-blind, placebo-controlled trial that enrolled 5674 patients with CKD related to T2D. All patients were on standard of care treatment at study entry, including maximum tolerated dose of an ACE or ARB. Compared with placebo, finerenone was associated with an 18% reduction in risk for progression of CKD and a 16% reduction in risk of the composite CV endpoint.
Recently announced data from 3 prespecified subanalyses of FIDELIO-DKD demonstrated no impact on finerenone efficacy of baseline treatment with insulin, GLP-1 receptor agonists or SGLT-2 inhibitors.
“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 percent of all patients with type 2 diabetes develop chronic kidney disease,” said Kevin Longino, CEO of the National Kidney Foundation, and a kidney transplant patient. “It is important for physicians and patients to have new treatment options that can slow chronic kidney disease progression.”
Per labeling, finerenone is initiated at a dose of 10 or 20 mg orally once daily as determined by eGFR and serum potassium thresholds. Titration begins after 4 weeks to the target dose of 20 mg.
The most common adverse reactions listed in the finerenone prescribing information are hyperkalemia, hypotension, and hyponatremia. Finerenone use is contraindicated with strong CYP3A4 inhibitors and in patients with adrenal insufficiency.
Marketed by Bayer as Karendia, finerenone is expected to be available in the US at the end of July 2021, according to the press statement. The company also has made a submission for marketing authorization in the European Union.