The European Medicines Agency’s CHMP has recommended approval of Sanofi’s BTK inhibitor Cenrifki (tolebrutinib) for a targeted subgroup of patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS), reversing the outcome of an earlier U.S. FDA complete response letter. CHMP’s opinion is grounded in the 1,131-patient Phase III HERCULES study, supplemented by GEMINI 1 and GEMINI 2 data in relapsing MS. CHMP said Cenrifki’s benefits 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 EU review matters for Sanofi because it reopens a pathway to the first European market entry for a brain-penetrant BTK inhibitor in this disease state, despite FDA concerns raised in December. If CHMP guidance translates into final EU authorization, it would give Sanofi a new competitive foothold in progressive MS. Separately, EMA aligned with FDA on another MS-related decision involving Arrowhead’s APOC3-targeting siRNA Redemplo for familial chylomicronemia syndrome—highlighting that regulators are increasingly converging on evidence expectations across similar review tracks.