Finerenone Gets Priority Review for Diabetic Kidney Disease
The FDA has accepted for Priority Review the NDA for finerenone for chronic kidney disease in patients with type 2 diabetes.
The FDA has accepted for Priority Review the NDA for finerenone for chronic kidney disease 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.
Finerenone vs placebo added to standard therapy was associated with a significant 18% reduction in the risk for major adverse kidney events in patients with both chronic kidney disease and type 2 diabetes mellitus.
In a trial, empagliflozin reduced the risks for heart failure hospitalization and renal outcomes in patients with heart failure with reduced ejection fraction.
Early results from the phase 3 FIDELIO-DKD study also show that finerenone reduces the risk for a cardiovascular secondary endpoint in patients with diabetic kidney disease.