Bayer’s Kerendia wins FDA priority review for type 1 diabetes kidney disease use

  • Bayer’s Kerendia (finerenone) won FDA Priority Review for a supplemental application to treat adults with type 1 diabetes and chronic kidney disease.
  • The filing was backed by the Phase III FINE-ONE trial, which showed a significant reduction in urine albumin-to-creatinine ratio over six months versus placebo.
  • Kerendia is already approved in the US for chronic kidney disease linked to type 2 diabetes, with an additional approval in July 2025 for heart failure with left ventricular ejection fraction of at least 40%.


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