Sanofi faces negative EU opinion on Rezurock

Sanofi, the biopharmaceutical company, has received a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) for Rezurock (belumosudil) in the European Union. This medicine is intended for the third-line treatment of chronic graft-versus-host disease (cGVHD). Sanofi has announced its intention to request a review of this decision.

cGVHD is a serious complication occurring after stem cell transplantation, affecting nearly 50% of patients. Despite the CHMP opinion, Sanofi continues to believe in the safety and efficacy of Rezurock, which is approved in 20 countries, including the United States, for patients who have failed at least two prior therapies.

Sanofi remains committed to working with the European Agency to make this treatment available in the EU, based on robust clinical data demonstrating durable and positive patient outcomes.