EU Approves Tolebrutinib for Nonrelapsing Secondary Progressive Multiple Sclerosis, First Disability-Targeting Therapy in Indication

The European Commission has approved tolebrutinib (Cenrifki; Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years. This marks the first therapy specifically designed to target disability progression in this patient population. The approval is based on results from the Phase 3 HERCULES trial and supporting data from the GEMINI 1 and 2 studies.