Roche’s Oral MS Drug Tops Teriflunomide, Matches Ocrevus in Late Trials

Overview

• Roche reported that fenebrutinib significantly reduced annual relapse rates versus Sanofi’s Aubagio (teriflunomide) in a Phase 3 trial for relapsing multiple sclerosis.
• In primary progressive multiple sclerosis, fenebrutinib was non-inferior to Roche’s Ocrevus at slowing disability progression in a study of about 1,000 participants followed for at least 120 weeks using a composite measure.
• Fenebrutinib is an oral Bruton's tyrosine kinase inhibitor, offering a different mechanism from CD20-targeting B‑cell therapies such as Ocrevus and TG Therapeutics’ Briumvi.
• The BTK class has drawn FDA scrutiny, including partial clinical holds and liver‑injury concerns, which remain a consideration as Roche advances fenebrutinib.
• Analysts flagged open regulatory questions, including whether non‑inferiority supports approval in primary progressive MS and how a second relapsing trial readout due in the first half of 2026 could shape filings.