The European Commission has approved tolebrutinib (Cenrifki/Sanofi) for adults with secondary progressive multiple sclerosis who haven’t relapsed in the past two years. The approval, granted in June 2026, was based on the Phase 3 HERCULES trial, which showed the oral BTK inhibitor cut the risk of six-month confirmed disability progression by 31% versus placebo.
The decision puts the EU at odds with the FDA, which rejected the same drug for the same indication in December 2025. The FDA’s complete response letter cited a “substantial and unusually high” risk of severe, sometimes fatal drug-induced liver injury, and concluded no patient subgroup had a clearly favorable benefit-risk profile. European regulators weighed the same safety signal but judged it manageable through close monitoring, given the lack of any other approved option for this stage of MS.
Cenrifki will carry “additional monitoring” status in the EU, with regular liver function checks built into its use. Sanofi says it remains in discussions with the FDA on a possible path forward in the U.S.
