The European Medicines Agency (EMA) has recommended conditional marketing authorization for Rezurock (belumosudil) to treat chronic graft-versus-host disease (GvHD) in adults and children aged 12 and older weighing at least 40 kg. This approval addresses unmet medical needs when other treatments fail or are unsuitable. Chronic GvHD, a severe condition where donor cells attack the host body, affects multiple organs and impairs quality of life. Current therapies, such as corticosteroids, often have limited long-term efficacy and significant side effects. Rezurock, a protein kinase inhibitor, blocks ROCK2, a protein involved in immune reactions. In a 6-month study, 73% of patients responded to treatment, with 68% showing partial improvement. Common side effects include fatigue, diarrhea, and elevated liver enzymes. Conditional approval allows earlier access despite incomplete data, pending confirmatory trials. The European Commission will now decide on EU-wide authorization, with national reimbursement decisions to follow.
© European Medicines Agency (1995‑).
Summary adapted from EMA materials available at https://www.ema.europa.eu
https://www.ema.europa.eu/en/news/new-medicine-treat-chronic-graft-versus-host-disease
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