Sanofi’s tolebrutinib (branded Cenrifki) cleared another regulatory hurdle as the European Medicines Agency’s CHMP issued a positive opinion for approval in a defined non-relapsing secondary progressive multiple sclerosis population. The decision follows the FDA’s December complete response letter, setting up a different approval route across regulators. CHMP’s recommendation is supported by data from Sanofi’s Phase III HERCULES study in nrSPMS, alongside evidence from GEMINI 1 and GEMINI 2 in relapsing MS. CHMP’s review attributes benefit to clinically meaningful reductions in disability progression risk and lesion activity versus placebo in the trial dataset. The divergent outcome underscores how endpoint selection and safety interpretations can vary between agencies, with Cenrifki positioned for potential first approval in Europe for this specific patient segment.