Europe’s regulator moved to approve Sanofi’s tolebrutinib for a subset of multiple sclerosis patients after the FDA previously issued a complete response letter. The EMA’s CHMP recommended approval for patients without relapses in the prior two years, aligning the EU decision with Phase III HERCULES data for non-relapsing secondary progressive MS. The CHMP opinion diverges from the FDA’s December stance, but also cites supportive evidence from Sanofi’s relapsing MS program (including GEMINI 1 and GEMINI 2). Cenrifki is positioned as an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor targeting smoldering neuroinflammation driving disability progression. Sanofi will need to complete downstream steps for EU authorization, but the CHMP recommendation reinforces how benefit-risk profiles can vary by jurisdiction and patient phenotype definition.