Bayer's KERENDIA® (finerenone) Granted Priority Review of Supplemental New Drug Application by U.S. FDA for Treatment of Adults with Type 1 Diabetes and Chronic Kidney Disease

The U.S. Food and Drug Administration (FDA) has accepted Bayer’s supplemental New Drug Application (sNDA) for KERENDIA (finerenone) and granted Priority Review for its potential use in treating adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The decision follows results from the Phase III FINE-ONE trial, which demonstrated that adding finerenone to standard care significantly reduced urine albumin-to-creatinine ratio (UACR) over six months compared to placebo. UACR is a key marker for cardiovascular risk and kidney disease progression, and the trial included 242 participants with T1D and CKD. The sNDA submission also incorporated pooled Phase III data from the FIDELIO-DKD and FIGARO-DKD trials, which evaluated finerenone in adults with CKD linked to type 2 diabetes (T2D). Approximately 20-30% of people in the U.S. with T1D also have CKD, placing them at higher risk for cardiovascular events and kidney failure. The FDA’s Priority Review designation reflects the potential for KERENDIA to offer a significant improvement in treatment for this serious condition. KERENDIA, a non-steroidal mineralocorticoid receptor antagonist (MRA), is currently approved for reducing cardiovascular and kidney-related risks in adults with CKD associated with T2D and for heart failure with reduced ejection fraction (HF LVEF ≤40%). If approved for T1D and CKD, it would mark the first such therapy for this patient population since the 1990s. The FINE-ONE trial showed finerenone’s safety profile was consistent with prior studies, though hyperkalemia occurred more frequently in the treatment group (10.1%) compared to placebo (3.3%). Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer, stated the FDA’s acceptance underscores the clinical importance of KERENDIA’s expanding evidence base across cardiovascular and kidney diseases. The company has now completed five Phase III trials with positive primary endpoints, bringing it closer to addressing unmet needs in T1D and CKD management. The FDA’s review process for Priority Review designation is expected to be completed within six months.