Rezurock approved to treat chronic graft vs host disease

Sanofi announces that the EC has granted a conditional marketing authorisation for Rezurock for the treatment of 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 medicine is to be used when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted.

“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 Hôpital Saint-Antoine and Sorbonne University, Paris, France. “This approval represents an important advance, offering a new therapeutic option that has the potential to meaningfully improve the lives of patients.”

“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 have remained limited,” said Olivier Charmeil, Executive Vice President, General Medicines, and Interim CEO, Sanofi. “We have an ongoing commitment to supporting patients with chronic GVHD and their caregivers and are pleased to deliver this new treatment option to patients living with this debilitating and long-term condition.”

Note that this approval was based on safety and efficacy results from several clinical studies and real-world evidence. This includes the randomised, multicenter ROCKstar phase 2 study, which demonstrated clinically meaningful and durable responses with Rezurock in patients living with chronic GVHD after stem cell transplant and at least two prior lines of systemic therapy. Treatment was generally well tolerated. Under the conditional marketing authorisation, Sanofi will conduct a new, confirmatory, randomised, controlled study.

In addition, the medicine was designated ‘orphan’ in 2019 for the treatment of graft-versus-host disease. Following this conditional marketing authorisation, the Committee for Orphan Medicinal Products of the European Medicines Agency has also formally adopted an opinion on the maintenance of orphan designation.

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Related Topics and Keywords

chronic graft-vs-host disease, Sanofi’s Rezurock