Roche says FDA accepts fenebrutinib MS filing for priority review
The FDA accepted Roche’s fenebrutinib application for relapsing and primary progressive MS for priority review. In phase III trials, the drug cut annualized relapse rates by 51.1% and 58.5% versus teriflunomide and met non-inferiority versus Ocrevus on disability progression, with a 12% numerical risk reduction.
1. FDA priority review
The FDA accepted Roche’s fenebrutinib application for relapsing MS and primary progressive MS for priority review. Over 96 weeks, phase III relapsing MS trials showed annualized relapse rate reductions of 51.1% and 58.5% versus teriflunomide. In primary progressive MS, fenebrutinib met non-inferiority versus Ocrevus on disability progression, with a 12% numerical risk reduction.
