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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

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  • Bayer announced that the FDA accepted its supplemental New Drug Application (sNDA) for KERENDIA (finerenone) and granted Priority Review designation for use in adults with type 1 diabetes (T1D) & chronic kidney disease (CKD).
  • If approved, KERENDIA would be the first non-steroidal mineralocorticoid receptor antagonist (MRA) indicated for this specific patient population.
  • The sNDA is supported by the Phase III FINE-ONE trial, which demonstrated that KERENDIA significantly reduced urine albumin-to-creatinine ratio (UACR) over six months compared to placebo in T1D patients with CKD.
  • Pooled Phase III data from the FIDELIO-DKD & FIGARO-DKD trials in adults with type 2 diabetes (T2D) & CKD also supported the application.
  • The FINE-ONE study enrolled 242 adult participants & found that 10 mg or 20 mg daily doses of finerenone were superior to placebo in reducing UACR (LS mean change = 0.75; P<0.001).
  • Safety results from FINE-ONE showed treatment-emergent adverse events occurred in 47.1% of the finerenone group vs 49.2% for placebo, with serious adverse events at 11.8% vs 11.5%.
  • Hyperkalemia was observed more frequently with finerenone (10.1%) compared to placebo (3.3%), resulting in a 1.7% treatment discontinuation rate for finerenone vs 0% for placebo.
  • KERENDIA is currently FDA-approved to reduce cardiovascular & kidney risks in adults with CKD associated with T2D & for heart failure with left ventricular ejection fraction ≥40%.
  • Approximately 20-30% of U.S. adults with T1D have CKD, placing them at risk for cardiovascular events & kidney failure.
  • FINE-ONE is the first Phase III study since the 1990s to show positive results for patients with T1D & CKD, with detailed results published in the New England Journal of Medicine in 2026.
  • Current contraindications for KERENDIA include hypersensitivity, concomitant use with strong CYP3A4 inhibitors, & patients with adrenal insufficiency.
  • Warnings include risks of hyperkalemia & worsening renal function, requiring serum potassium & eGFR monitoring before & during treatment.
  • Bayer's FINEOVATE clinical trial program comprises 10 Phase III studies dedicated to heart failure & CKD treatment.