Roche's Fenebrutinib Delays MS Relapses in Phase 3 Trials but Faces Liver Toxicity and Safety Scrutiny

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Roche's oral BTK inhibitor fenebrutinib reduced annualized relapse rates by 51% in FENhance 1 and 59% in FENhance 2 compared to teriflunomide (Aubagio) in relapsing MS (RMS) patients.123

Roche plans regulatory filings worldwide for fenebrutinib in RMS and primary progressive MS (PPMS) following positive phase 3 results.12

Elevations in liver transaminases were comparable to teriflunomide, with one asymptomatic Hy’s Law case in each arm of FENhance 1; no other Hy’s Law cases across the program.13

Eight deaths occurred in fenebrutinib arms across FENhance 1 and 2 vs. one in teriflunomide arms; causes varied and analyses are ongoing.123

FDA previously rejected Sanofi's similar BTK inhibitor tolebrutinib over liver injury risks, raising the bar for fenebrutinib approval.13

Sources:

1. https://pharmaphorum.com/news/after-phase-3-clean-sweep-roche-plans-oral-btk-filing-ms

2. https://www.statnews.com/2026/04/21/roche-multiple-scleroris-efficacy-safety/

3. https://www.fiercebiotech.com/biotech/roche-reports-another-pivotal-multiple-sclerosis-win-deaths-add-safety-questions