The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application for finerenone (Bayer), a nonsteroidal selective mineralocorticoid receptor antagonist, for the treatment of chronic kidney disease (CKD) in patients with type 2 diabetes.
The NDA submission is based on data from the double-blind, placebo-controlled phase 3 FIDELIO-DKD trial that assessed the efficacy and safety of finerenone, in addition to standard of care, in 5734 patients with CKD and type 2 diabetes. Patients were randomized 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 estimated glomerular filtration rate from baseline, or death from renal causes. 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 (504/2833) in the finerenone arm compared with 21.1% of patients (600/2841) in the placebo arm (hazard ratio [HR] 0.82; 95% CI, 0.73-0.93; P =.001). Additionally, treatment with finerenone was associated with a lower incidence of the secondary outcome event (13% vs 14.8% for placebo; HR 0.86; 95% CI, 0.75-0.99; P =.03).
As for safety, the overall frequency of adverse events was similar between finerenone and placebo. The finerenone arm was observed to have a higher incidence of hyperkalemia-related discontinuation compared with placebo (2.3% vs 0.9%, respectively).
“Based on study data, finerenone offers a potential new strategy to delay CKD progression, while reducing the risk of cardiovascular events,” said Dr Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer. “We’re encouraged that the FDA has granted the NDA a Priority Review, as it potentially expedites our ability to make finerenone available to patients.”
The FDA’s Priority Review designation means that the Agency will take action on the application within 6 months, compared to 10 months under standard review.
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Bayer announces U.S. FDA accepts New Drug Application and grants Priority Review for investigational drug finerenone for patients with chronic kidney disease and type 2 diabetes. [press release]. Whippany, NJ: Bayer; January 12, 2021.