Finerenone receives updated label to include data from patients with CKD, diabetes
Bayer has received FDA approval to update to the label for finerenone, a nonsteroidal mineralocorticoid receptor antagonist, according to a press release.
The updated label will include information from the FIGARO-DKD and FIDELIO-DKD trials, which examined kidney and CV outcomes for patients with chronic kidney disease associated with type 2 diabetes.
Finerenone (Kerendia, Bayer) reduces the risk of sustained estimated glomerular filtration rate decline, CV death, end-stage kidney disease, non-fatal myocardial infarction and hospitalization for heart failure.
The label now includes a warning stating finerenone can cause hyperkalemia.
“The FIDELIO-DKD and FIGARO-DKD studies demonstrated Kerenedia’s dual cardiorenal risk reduction in patients with chronic kidney disease associated with type 2 diabetes,” George Bakris, MD, principal investigator of the trial and professor at the University of Chicago Medicine, said in a press release. “This label update reaffirms [finerenone] as a fundamental pillar in the treatment algorithm to improve cardiovascular and renal outcomes in patients with chronic kidney disease associated with type 2 diabetes.”
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