Sanofi’s tolebrutinib program for non-relapsing secondary progressive multiple sclerosis cleared another hurdle in Europe after the FDA issued a complete response letter in the U.S. Earlier FDA feedback on safety concerns delayed U.S. progress, but the EMA’s CHMP issued a positive opinion recommending approval for Cenrifki in a defined patient subset. The CHMP opinion targets patients without relapses in the prior two years and builds on the Hercules Phase III dataset, supported by Gemini 1 and Gemini 2 trials in relapsing MS. Separate reporting noted the EU endorsement follows the FDA rejection, setting up a first approval opportunity for an oral, brain-penetrant Bruton’s tyrosine kinase inhibitor aimed at smoldering neuroinflammation. For MS developers and investors, the cross-regional path highlights how label design and post-CRL requirements can diverge across regulators even when efficacy data are otherwise aligned.