FDA approves Kerendia for the treatment of CKD, type 2 diabetes
The FDA approved Kerendia for reducing the risk for kidney and heart complications among adults with chronic kidney disease associated with type 2 diabetes.
In a randomized, multicenter, double-blind study, researchers compared the efficacy of Kerendia (finerenone) tablets with placebo among 5,674 patients with CKD. According to study results, 504 patients of 2,833 patients who received Kerendia experienced a composite endpoint of either a 40% reduction in kidney function, progression to kidney failure or kidney death vs. 600 patients out of 2,841 patients who received placebo. Further, cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization occurred in 367 patients who received Kerendia vs. 420 patients who received placebo, respectively.
Kerendia received priority review as well as fast track designations.