Roche's Fenebrutinib Granted FDA Priority Review for MS Treatment

The U.S. FDA has accepted Roche's New Drug Application for fenebrutinib, an oral BTK inhibitor, granting it priority review for both relapsing and primary progressive multiple sclerosis. This decision follows Phase 3 studies demonstrating the drug's effectiveness in reducing relapses and lesions in RMS, and its non-inferiority to ocrelizumab in slowing disability progression in PPMS, potentially offering a new treatment option for patients.