Sanofi’s tolebrutinib, marketed as Cenrifki for secondary progressive multiple sclerosis, received a positive European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation despite an FDA complete response letter last December. The CHMP opinion supports approval for patients without relapses in the prior two years, aligning with results from the HERCULES Phase III study and supporting data from GEMINI 1 and GEMINI 2. The regulatory action sets up a potential EU approval path for the oral, brain-penetrant Bruton’s tyrosine kinase (BTK) inhibitor. In CHMP review, the benefit profile included a 31% reduction in the risk of six-month confirmed disability progression and a 38% reduction in the adjusted mean number of new or enlarging T2-hyperintense lesions per year versus placebo. The FDA had previously rejected the therapy in the U.S., framing this as a key geographic reversal in regulatory posture. For Sanofi, the CHMP endorsement extends the company’s late-stage MS development momentum in a category where disability progression remains a central endpoint.