Roche Receives FDA Approval for Fenebrutinib in Relapsing Multiple Sclerosis

Roche today announced that the FDA has approved fenebrutinib for the treatment of adults with relapsing forms of multiple sclerosis, including relapsing-remitting MS and active secondary progressive MS. In the Phase 3 FENhance trials, fenebrutinib demonstrated statistically significant reductions in annualized relapse rate and confirmed disability progression compared to comparators. Fenebrutinib is a highly selective, non-covalent BTK inhibitor that targets both peripheral B cells and CNS-resident microglia. This approval provides MS patients with a new oral treatment option.