The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Sanofi’s BTK inhibitor Cenrifki (tolebrutinib) for secondary progressive multiple sclerosis, diverging from an FDA complete response letter issued last December. CHMP’s positive opinion was based on the Phase III HERCULES trial, supported by GEMINI 1 and GEMINI 2 data. CHMP also issued a positive opinion for Arrowhead’s APOC3-targeting siRNA Redemplo (denoted as “Redemplo” in the report) for familial chylomicronemia syndrome, a decision that could make the therapy the first in Europe for the condition. The CHMP alignment with the FDA on the overall benefit-risk in both programs sets the stage for regional review outcomes.