Roche says FDA accepts fenebrutinib MS filing for priority review

PUBT · 2d ago
Roche says FDA accepts fenebrutinib MS filing for priority review
  • Roche’s US FDA accepted its fenebrutinib NDA for relapsing MS, primary progressive MS under priority review.
  • Phase III RMS trials cut annualized relapse rates by 51.1% and 58.5% versus teriflunomide over 96 weeks.
  • In PPMS, fenebrutinib met non-inferiority versus Ocrevus on disability progression, showing a 12% numerical risk reduction.


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