Europe moved to greenlight Sanofi’s MS therapy Cenrifki (tolebrutinib) after U.S. regulators previously rejected it. Sanofi received a positive CHMP opinion for Cenrifki for non-relapsing secondary progressive multiple sclerosis. The review follows a December FDA complete response letter for the same drug, which cited concerns that prevented approval in the U.S. The European recommendation is based on the 1,131-patient Phase III HERCULES study, supported by GEMINI 1 and GEMINI 2 data from relapsing MS. CHMP said the benefits included a 31% reduction in risk of six-month confirmed disability progression and a 38% reduction in adjusted mean new or enlarging T2-hyperintense lesions versus placebo. Separately, an EMA endorsement for Cenrifki also signals how regulators are weighing evidence in progressive, non-relapsing MS subpopulations—an outcome that could reshape Sanofi’s commercial timeline across the EU.