The European Commission has granted conditional marketing authorisation to Rezurock (belumosudil) for the treatment of chronic Graft-Versus-Host Disease (GVHD) in adults and children aged 12 years and above, weighing at least 40 kg. The therapy is intended for patients who have exhausted or are unsuitable for existing treatment options.

The approval follows a positive recommendation issued on January 30, 2026, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. The authorisation is conditional upon the completion of a confirmatory randomised controlled study to further validate the drug’s efficacy and safety.

Chronic GVHD remains a serious and potentially life-threatening complication that can occur after allogeneic stem cell transplantation, often placing significant physical and emotional strain on patients. According to Mohamad Mohty, Professor of Haematology at Hôpital Saint-Antoine and Sorbonne University, the condition continues to pose major treatment challenges, particularly when standard therapies fail. He noted that the approval introduces a promising new option that could improve patient outcomes.

Olivier Charmeil, Executive Vice President of General Medicines and Interim CEO at Sanofi, highlighted that nearly half of chronic GVHD patients require third-line treatment, where therapeutic options remain limited. He said the approval reflects the company’s commitment to addressing unmet medical needs in this patient group.

The decision is supported by data from multiple clinical studies, including the Phase II ROCKstar trial, which demonstrated a best overall response rate of 74 percent among patients who had previously undergone at least two lines of systemic therapy. The treatment was generally well tolerated, with common side effects including fatigue, diarrhoea, nausea and respiratory symptoms.

Rezurock, a selective ROCK2 inhibitor, had previously received orphan drug designation in 2019 for GVHD. Following the latest approval, the Committee for Orphan Medicinal Products has endorsed the continuation of its orphan status.

The drug is already approved in more than 20 countries, including the United States, United Kingdom and Canada, and has been used to treat over 20,000 patients globally since its initial approval in 2021.

Sanofi is continuing to evaluate Rezurock in additional patient groups and indications, including paediatric populations as young as one year and patients with chronic lung allograft dysfunction, as part of ongoing clinical studies.

Chronic GVHD affects up to 50 percent of patients undergoing allogeneic stem cell transplantation and remains a leading cause of long-term complications and mortality, underscoring the importance of expanding treatment options in this area.