EMA CHMP turns positive on Sanofi’s MS therapy while diverging on an FDA setback

EMA’s CHMP recommended approval of Sanofi’s BTK inhibitor Cenrifki (tolebrutinib) for secondary progressive multiple sclerosis at its April meeting, following a different outcome on the U.S. side. FDA had issued a December complete response letter, and CHMP’s positive recommendation runs counter to that earlier FDA decision. In CHMP’s assessment, the decision for Cenrifki was supported by the 1,131-patient Phase III HERCULES trial, plus data from GEMINI 1 and GEMINI 2. CHMP cited 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.