Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis
Basel, 30 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The filing acceptance is based on data from the comprehensive clinical programme, including the Phase III FENhance 1 and 2 RMS studies and the Phase III FENtrepid PPMS study. 1,2