Roche | MEDIA
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Roche’s fenebrutinib significantly reduced relapses versus standard of care to approximately one every 17 years in RMS
Roche announced positive results from Phase III FENhance 1 and 2 studies of fenebrutinib in relapsing multiple sclerosis (RMS). The studies demonstrated fenebrutinib's superiority over teriflunomide in reducing annualized relapse rates and brain lesions. Fenebrutinib reduced relapse rates by over 50% compared to teriflunomide and significantly decreased brain disease activity. Positive trends were observed in reducing disability progression with fenebrutinib in both studies. Liver enzyme elevations were comparable between fenebrutinib and teriflunomide, although there were more deaths in the fenebrutinib arm. Fenebrutinib is a novel BTK inhibitor that targets both relapsing and progressive aspects of MS. A previous study, FENtrepid, showed non-inferiority of fenebrutinib versus OCREVUS in primary progressive MS (PPMS). Fenebrutinib could potentially be a first-in-class oral treatment option for both RMS and PPMS. Roche plans to submit the complete data from all three Phase III studies to regulatory authorities.