Sanofi (SNY) has received conditional marketing authorization from the European Commission for Rezurock to treat chronic graft-versus-host disease in adults and in children aged 12 years and older with a body weight of at least 40 kg.
The approval provides a new option for patients whose disease persists despite multiple prior treatments, a group that continues to face limited therapeutic choices.
Chronic graft-versus-host disease (GVHD) is a serious and often life-altering complication that can occur after an allogeneic stem cell transplant, when donor immune cells attack the patient's tissues. The condition can affect multiple organs, leading to inflammation, scarring and long-term disability. Nearly half of patients require third-line treatment, yet options in Europe have remained scarce.
Rezurock (belumosudil) is a selective ROCK2 inhibitor designed to reduce inflammation and fibrosis. The EU decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and is supported by data from several clinical studies, including the Phase 2 ROCKstar trial. In that study, Rezurock achieved a 74% overall response rate, with durable and clinically meaningful improvements in patients who had already received two to five prior systemic therapies. Treatment was generally well tolerated.
Rezurock is already approved in the United States, Canada, the United Kingdom, and more than 20 countries for chronic GVHD after failure of at least two prior lines of systemic therapy. The drug was first approved by the U.S. FDA in July 2021. More than 20,000 patients worldwide have been treated since its initial launch.
Sanofi noted that the EU authorization is conditional and requires completion of a new confirmatory randomized controlled study. The company is also evaluating Rezurock in additional age groups and potential new indications, including pediatric patients as young as one year old and individuals with chronic lung allograft dysfunction. These programs are still under evaluation.
Chronic GVHD is a debilitating condition that affects up to half of transplant recipients, and many patients eventually exhaust available therapies, said Oliver Charmeil, Sanofi's Executive Vice President, General Medicines, and Interim CEO. "Rezurock offers a meaningful new option for patients who have long needed additional treatment choices."
SNY has traded between $43.32 and $55.77 over the past year. The stock closed Monday's trading at $46.72, down 0.13%. In pre-market the stock is at $47.61, up 1.90%.
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