FDA accepts Bayer sNDA for Kerendia in chronic kidney disease without diabetes

PUBT · 2d ago
FDA accepts Bayer sNDA for Kerendia in chronic kidney disease without diabetes
  • FDA accepted Bayer’s supplemental NDA for Kerendia to treat adults with chronic kidney disease without diabetes.
  • Filing backed by Phase III FIND-CKD data showing slower eGFR decline versus placebo, with a 0.7 mL/min/1.73 m²/year difference.
  • Trial also cut risk on a kidney-cardiovascular composite endpoint, hazard ratio 0.77.
  • Safety broadly matched prior studies; hyperkalemia occurred in 17% on Kerendia versus 13.3% on placebo.


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