Europe’s regulator moved to support Sanofi’s multiple sclerosis franchise after the U.S. FDA rejected the drug. The EMA’s CHMP recommended approval of Cenrifki (tolebrutinib) for non-relapsing secondary progressive multiple sclerosis (nrSPMS) in patients without relapses in the prior two years. The CHMP opinion, discussed at its April meeting, aligns the EU path with Sanofi’s late-stage data package, including the Phase III HERCULES trial plus supporting results from GEMINI 1 and GEMINI 2 in relapsing MS. CHMP’s benefits analysis cited a 31% reduction in the risk of six-month confirmed disability progression and a 38% reduction in adjusted mean new or enlarging T2 lesions per year versus placebo. Separately, CHMP also issued a positive opinion for Arrowhead’s APOC3-targeting siRNA, Redemplo, for familial chylomicronemia syndrome, positioning it as a potential first-in-Europe approval for that indication.