Roche Receives FDA Approval for Fenebrutinib in Primary Progressive Multiple Sclerosis

Roche today announced that the FDA has approved fenebrutinib for the treatment of adults with primary progressive multiple sclerosis (PPMS). In the Phase 3 FENhance trials, fenebrutinib demonstrated statistically significant reductions in confirmed disability progression compared to comparators. This approval expands fenebrutinib's MS indications to include PPMS in addition to relapsing MS. Fenebrutinib is a highly selective, non-covalent BTK inhibitor that targets both peripheral B cells and CNS-resident microglia, addressing both inflammatory and neurodegenerative aspects of MS.