Shots:
- The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively
- FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively, over 96wks. Disability progression measures, incl. 12wk. cCDP12, also showed consistent positive trends favoring fenebrutinib
- FENtrepid met its 1EP of non-inferiority vs Ocrevus in reducing disability progression. Fenebrutinib numerically reduced cCDP12 risk by 12%, with curves separating as early as Wk. 24, & consistent effects were observed across subgroups, incl. pts without active inflammation
Ref: Globenewswire | Image: Roche | Press Release
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