Sanofi: Rezurock Treatment Receives European Green Light, Already 20,000 Patients Treated
The European Commission has granted conditional marketing authorization for Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease in adults and children aged 12 and over. This treatment is intended for patients for whom other therapeutic options provide limited clinical benefit, are inadequate, or have been exhausted.
Conditional Approval by the European Commission
The conditional authorization granted by the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued on January 30, 2026. This approval is contingent upon Sanofi completing a randomized, controlled confirmatory study. The drug was also designated as an 'orphan' drug in 2019 for the treatment of graft-versus-host disease, a designation maintained by the Committee for Orphan Medicinal Products following this authorization.
Approval Based on Clinical Studies and Real-World Data
The approval is based on the safety and efficacy results from several clinical trials and real-world data, including the phase 2, randomized, multicenter ROCKstar study. Sanofi is committed to investigating the safety and efficacy of Rezurock in other age groups and indications, including ongoing studies in pediatric patients with chronic GvHD from one year of age and in patients with chronic dysfunction of lung allografts. In addition to the EU, Rezurock is approved in 20 countries, including the United States, the United Kingdom, and Canada. Over 20,000 patients have been treated with Rezurock since its first approval in the United States in July 2021.
