Sanofi's Rezurock EU Approval Recommendation

The European Union===European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization for Sanofi's drug, Rezurock (belumosudil), in the EU. This recommendation is for the treatment of adults and children aged 12 years and older with chronic graft-versus-host disease (GVHD) when other treatment options are limited or exhausted. This positive opinion follows Sanofi's request for a re-examination after a prior negative opinion in October 2025. The decision is supported by safety and efficacy results from clinical studies, including the ROCKstar phase 2 study, and real-world evidence. Sanofi has also committed to conducting a new post-approval confirmatory study. The final decision from the European Union===European Commission is anticipated in the coming weeks. Rezurock is already approved in 20 countries, including the US, UK, Canada, and China.