EU Approved Sanofi's Rezurock for Chronic GVHD Treatment

Sanofi has secured a conditional marketing authorization for Rezurock (belumosudil) in the EU, marking a major step forward in chronic GVHD treatment.

The approval allows use in adults and children aged 12 and older weighing at least 40 kg, especially when existing therapies no longer deliver results.

The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on January 30, 2026. The Rezurock EU approval is conditional, requiring a confirmatory randomized controlled study to    validate long-term benefits.

“Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation. Across the EU, many patients continue to face significant challenges in managing this disease, particularly when existing therapies fail to provide adequate benefit,” said Mohamad Mohty, Professor of Haematology and Head of the Haematology and Cellular Therapy Department at Hopital Saint-Antoine and Sorbonne University, Paris, France.

Also Read: How Digital Maturity is Powering Pharma's GMP Evolution

“Nearly one in two patients with chronic GVHD require third-line treatment, yet therapeutic options available for EU patients at this late stage of the disease ha ve remained limited,” said Olivier Charmeil, executive vice president, general medicines, and Interim CEO, Sanofi.

The approval is backed by data from the ROCKstar phase 2 study, which showed a 74 percent overall response rate in heavily pretreated patients. Treatment was generally well tolerated, with fatigue, diarrhea, nausea, and respiratory issues among the most common side effects.

Already approved in over 20 countries, including the US, UK, and Canada, Rezurock for chronic GVHD has been used by more than 20,000 patients since 2021. The drug works by selectively inhibiting ROCK2, helping regulate immune response.