Sanofi's Rezurock recommended for EU approval to treat chronic GVHD

Company: Sanofi

Sanofi's Rezurock Recommended for EU Approval for Chronic GVHD

Paris – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional marketing authorization of Sanofi’s Rezurock (belumosudil). The medicine is intended for the treatment of chronic graft-versus-host disease (GVHD) in adults and in children aged 12 years and older, weighing at least 40 kg, when other treatment options have provided limited clinical benefit, are not suitable, or have been exhausted.

This positive recommendation follows Sanofi's request for a re-examination of the CHMP's prior negative opinion issued in October 2025. A final decision from the European Commission is expected in the coming weeks.

The CHMP's recommendation is based on safety and efficacy results from several clinical studies and real-world evidence. This includes the randomized, multicenter ROCKstar phase 2 study, which demonstrated clinically meaningful and durable responses with Rezurock for patients with chronic GVHD after stem cell transplant and at least two prior lines of systemic therapy. The treatment was generally well tolerated.

Chronic GVHD can involve multiple organs and profoundly affect patients’ daily lives. “For patients who have exhausted available treatment options, this positive opinion marks an important step forward in our ability to better manage this challenging disease,” said Professor Mohamad Mohty, Professor of Hematology at Hôpital Saint-Antoine in Paris.

Rezurock is already approved in 20 countries, including the U.S., UK, and Canada, for the treatment of patients 12 years and older with chronic GVHD after failure of at least two prior lines of systemic therapy. As part of the conditional marketing authorization, Sanofi will also conduct a confirmatory randomized controlled study.