EMA’s CHMP has recommended approval of Sanofi’s tolebrutinib for a defined subset of non-relapsing secondary progressive multiple sclerosis, a reversal for the program after the FDA issued a December complete response letter. The CHMP opinion aligns with FDA on the overall dataset but carves out benefit for patients who have not relapsed for a specified period. The CHMP recommendation cites Phase III HERCULES data plus supporting evidence from GEMINI 1 and GEMINI 2. CHMP’s review reportedly points to reduced disability progression risk and lower rates of new or enlarging T2 lesions versus placebo, based on the company’s pivotal study results. The European step keeps the drug’s EU path alive while U.S. review remains stalled, underscoring how regulator-specific benefit definitions can determine approval timing even for the same clinical evidence package.