FDA accepts Genentech fenebrutinib NDA for relapsing, primary progressive multiple sclerosis under priority review

PUBT · 2d ago
FDA accepts Genentech fenebrutinib NDA for relapsing, primary progressive multiple sclerosis under priority review
  • FDA accepted Genentech’s NDA for fenebrutinib for relapsing MS, priority review granted.
  • Filing also covers primary progressive MS, marking the first BTK inhibitor accepted for both MS forms.
  • Phase III FENhance trials cut relapse rates 51.1% to 58.5% versus teriflunomide over 96 weeks.
  • Phase III FENtrepid met non-inferiority to Ocrevus in PPMS disability progression, showing a 12% numerical risk reduction.


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