Bayer said the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for Kerendia® (finerenone). The application seeks to expand the drug’s use to adults with chronic kidney disease (CKD) who do not have diabetes. It is supported by positive results from the Phase III FIND-CKD study.
The proposed indication could extend finerenone’s use to a new patient population. Kerendia is already approved for certain patients with heart failure and for CKD associated with type 2 diabetes. If approved for CKD without diabetes, the expanded indication would broaden the drug’s role in treating kidney disease and related cardiovascular issues.