Europe’s regulators moved forward on Sanofi’s multiple sclerosis program after the U.S. FDA rejected the company’s BTK inhibitor strategy. The EMA’s CHMP recommended approval for Cenrifki (tolebrutinib) for a defined patient population with non-relapsing secondary progressive MS, aligning with efficacy signals from the Phase III HERCULES program and supportive GEMINI 1 and GEMINI 2 data. CHMP’s recommendation reflects outcomes reported as 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 lesions versus placebo in the HERCULES trial. The endorsement narrows the label to patients without relapses in the prior two years. The decision comes after the FDA issued a complete response letter in December, creating a meaningful divergence in regulatory paths for the same asset. Sanofi now has a clearer route to an EU first approval in this MS subtype segment, pending final steps in the European process.