In parallel coverage of Sanofi’s MS regulatory pathway, reporting emphasized that tolebrutinib’s U.S. rejection contrasted with Europe’s momentum. After the FDA returned a complete response letter, the EMA’s CHMP recommendation reframed the benefit-risk assessment for a defined patient subset. The company’s dosing strategy and patient selection are central to how the therapy landed in Europe: the CHMP opinion focused on individuals without relapses in the last two years, backed by HERCULES and supporting GEMINI data. The move effectively positions Cenrifki for its first EU regulatory approval milestone in this indication. For MS developers, the episode underscores how endpoint assumptions and subgroup definitions can materially shift outcomes between regulators. It also provides a blueprint for how teams may refine indications when faced with U.S. refusals.