A New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) for finerenone (Bayer), a nonsteroidal selective mineralocorticoid receptor antagonist (MRA), for the treatment of chronic kidney disease (CKD) in patients with type 2 diabetes.
The NDA for finerenone is supported by 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).
“The findings from the FIDELIO-DKD study demonstrated the potential role of finerenone in improving outcomes in these patients by delaying CKD progression and reducing the risk for cardiovascular events,” said Joerg Moeller, MD, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “Those findings have informed these regulatory submissions, which are an important step towards providing finerenone as a potential new treatment option for these patient populations.”
For more information visit bayer.us.
- Bayer submits regulatory applications for investigational drug finerenone in the U.S. and the EU for patients with chronic kidney disease and type 2 diabetes. [press release]. Whippany, NJ: Bayer; November 9, 2020.
- Bakris GL, Agarwal R, Anker SD, et al. Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes. N Engl J Med. Published online October 23, 2020. doi: 10.1056/NEJMoa2025845.
This article originally appeared on MPR