Sanofi’s tolebrutinib (Cenrifki) avoided a repeat of its US rejection as the EMA’s CHMP recommended approval for patients with non-relapsing secondary progressive multiple sclerosis. The CHMP opinion diverges from the FDA’s December complete response letter, which previously blocked US approval on safety grounds. The European recommendation is grounded in the 1,131-patient Phase III HERCULES trial, supported by GEMINI 1 and GEMINI 2 data in relapsing MS. CHMP concluded the drug delivered risk reductions in disability progression and lesion dynamics versus placebo, positioning Cenrifki for an EU first approval in the defined patient group. Separately, the CHMP also issued a positive opinion for Arrowhead’s APOC3-targeting siRNA, Redemplo, for familial chylomicronemia syndrome—an EU first if approved. The combination of an MS path cleared in Europe and lipid therapy momentum highlights how trans-Atlantic review outcomes remain highly program- and patient-subset dependent.