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Bayer’s Kerendia Secures US FDA Approval for Chronic Kidney Disease Associated with T1D

Shots:

  • The US FDA has approved Kerendia (finerenone, 10 & 20mg) for the treatment of adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D)
  • Approval was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D
  • Kerendia + SoC reduced UACR by 25% over 6mos. (1EP); UACR reduction was 22% & 28% at 3 & 6mos., respectively. Additionally, at any time post-baseline, 68.1% pts achieved ≥30% UACR reduction vs 46.6%; data were published in The NEJM

Ref: Bayer  |  Image: Bayer  |  Press Release

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