US FDA Accepts Roche's New Drug Application for Multiple Sclerosis Treatment

01:24 AM EDT, 09/30/2026 (MT Newswires) -- Roche's (RO.SW) new drug application for its investigational treatment for multiple sclerosis, fenebrutinib, was accepted by the US Food and Drug Administration. The acceptance was supported by the Swiss drugmaker's Phase 3 Fenhance 1 and 2 RMS trials and the Phase 3 Fentrepid PPMS study, according to a Wednesday release. The company noted that if the application is approved, fenebrutinib would be the first oral Bruton's tyrosine kinase inhibitor therapy for relapsing multiple sclerosis and primary progressive multiple sclerosis.