Sanofi: Positive CHMP Opinion for Rezurock in the EU
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended conditional marketing authorization for Sanofi's Rezurock (belumosudil) in the European Union. This medication is intended for the treatment of chronic graft-versus-host disease (GVHD) in adults and children aged 12 years and older weighing at least 40 kg.
Positive Recommendation Following Reassessment
This positive CHMP recommendation follows Sanofi's request for a reassessment of a previously adopted negative opinion in October 2025. Rezurock is indicated for patients with chronic GVHD when other therapeutic options provide limited clinical benefit, are inadequate, or have been exhausted. The final decision from the European Commission is expected in the coming weeks. This recommendation is based on safety and efficacy results from multiple clinical studies, including the phase 2 ROCKstar study, as well as real-world data.
Conditional Marketing Authorization Requirements
As a condition of the conditional marketing authorization, Sanofi is committed to conducting a post-approval randomized controlled confirmation study. Rezurock is the first selective ROCK2 inhibitor (Rho-associated coiled-coil kinase 2) developed by Sanofi. The drug is already approved in 20 countries, including the United States, the United Kingdom, and Canada. Sanofi is also continuing to evaluate the efficacy and safety of the medication in other age groups and indications, including pediatric patients and in chronic allograft pulmonary dysfunction, with studies currently ongoing and not yet approved by regulatory authorities.
