Roche’s Fenebrutinib Delivers Phase III Success Across MS Subtypes

Roche’s oral BTK inhibitor fenebrutinib has achieved key Phase III successes in multiple sclerosis (MS), positioning it for potential regulatory submission. In the FENhance 2 trial, the therapy significantly reduced annualised relapse rates over 96 weeks versus Sanofi’s Aubagio in patients with relapsing MS (RMS). In parallel, the FENtrepid study showed fenebrutinib to be non-inferior to Ocrevus, the only approved therapy for primary progressive MS (PPMS), with a sustained delay in disability progression across 120 weeks.

These results build on the Phase II FENopta extension, where the drug nearly eliminated disease activity over 96 weeks. A second RMS study, FENhance, is expected to read out in 2026 before Roche seeks approval.

Safety findings align with prior data, though fenebrutinib previously faced an FDA clinical hold due to elevated liver enzymes. If approved, it would become the first BTK inhibitor authorised for both RMS and PPMS, supporting Roche’s strategy as Ocrevus approaches its 2029 patent expiry.

16-11-2025