Shots:
- The US FDA has accepted sNDA & granted Priority Review to Kerendia (finerenone) for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes (T1D)
- sNDA 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 plus SoC reduced UACR by 25% over 6mos. Additionally, at any time post-baseline, 68.1% pts (81/119) receiving Kerendia achieved ≥30% UACR reduction vs 46.6% (54/116) with PBO; data were published in The NEJM
Ref: Bayer | Image: Bayer |Press Release
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