FDA Accepts Roche's Fenebrutinib NDA Under Priority Review For Relapsing And Primary Progressive MS, Backed By Phase III Data Showing 51.1%, 58.5% Relapse Reductions Vs Teriflunomide

The FDA has accepted Roche's New Drug Application (NDA) for fenebrutinib under priority review for treating relapsing and primary progressive multiple sclerosis (MS), supported by Phase III trial data showing a 51.1% and 58.5% reduction in relapses compared to teriflunomide. Fenebrutinib is notable for being the first investigational medicine in over a decade to demonstrate a slowing of disability progression in a Phase III trial for primary progressive MS. If approved, it would be the first BTK inhibitor and high-efficacy oral treatment for both relapsing and primary progressive MS, potentially benefiting nearly 1 million Americans with the condition.