The Food and Drug Administration (FDA) has approved Kerendia® (finerenone) to reduce the risk of sustained estimated glomerular filtration (eGFR) decline, end stage kidney disease, cardiovascular death, nonfatal myocardial infarction (MI) and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Kerendia is a nonsteroidal selective mineralocorticoid receptor (MR) antagonist that works by blocking MR mediated sodium reabsorption and MR overactivation in both epithelial (eg, kidney) and nonepithelial (eg, heart and blood vessels) tissues. Mineralocorticoid receptor overactivation is believed to contribute to fibrosis and inflammation.
The approval was based on data from the multicenter, double-blind, placebo-controlled phase 3 FIDELIO-DKD trial (ClinicalTrials.gov Identifier: NCT02540993), which assessed the efficacy and safety of finerenone, in addition to standard of care, in 5674 patients with CKD associated with type 2 diabetes. Patients were randomly assigned 1:1 to receive finerenone or placebo.
The primary composite end point was the time to first occurrence of kidney failure, a sustained decrease of at least 40% in eGFR from baseline, or renal death. The key secondary composite end point was the time to first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
Results showed that after a median follow-up of 2.6 years, the primary outcome event occurred in 17.8% of patients (n=504/2833) in the finerenone arm compared with 21.1% of patients (n=600/2841) in the placebo arm (hazard ratio [HR] 0.82; 95% CI, 0.73-0.93; P =.001). Treatment with finerenone was also associated with a lower incidence of the secondary outcome event (13% [n=367/2833] vs 14.8% [n=420/2841] for placebo; HR 0.86; 95% CI, 0.75-0.99; P =.034). The most common adverse reactions reported with finerenone were hyperkalemia, hypotension, and hyponatremia.
“The patient population included in the trial that supported the approval of Kerendia was 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 people with chronic kidney disease associated with type 2 diabetes, physicians now have a new treatment to provide kidney protection.”
Kerendia is supplied as 10mg and 20mg tablets in 30- and 90-count bottles and is expected to be available at the end of July 2021.
- Bayer’s Kerendia® (finerenone) receives U.S. FDA approval for treatment of patients with chronic kidney disease associated with type 2 diabetes. [press release]. Whippany, NJ: Bayer; July 10, 2021.
- FDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes. [press release]. Silver Spring, MD: US Food and Drug Administration; July 9, 2021.
- Kerendia [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2021.
This article originally appeared on MPR