Rezurock recommended for EU approval to treat chronic graft-vs-host disease

The EMA’s CHMP has officially adopted a positive opinion recommending the conditional marketing authorisation of Rezurock in the EU for the treatment of adults and in children aged 12 years and older with a body weight of at least 40 kg, with chronic graft-versus-host disease. This medicine is to be used when other treatment options provide limited clinical benefit, are not suitable, or have been exhausted. This positive recommendation comes after Sanofi requested a re-examination of the prior negative opinion adopted by the CHMP in October 2025.

“Chronic GVHD can involve multiple organs and profoundly affect patients’ daily lives, limiting everyday activities and taking a substantial emotional toll,” said Prof Mohamad Mohty, Professor of Haematology, Head of the Haematology and Cellular Therapy Department at Hôpital Saint-Antoine and Sorbonne University, Paris, France. “For patients who have exhausted available treatment options, this positive opinion marks an important step forward in our ability to better manage this challenging disease.”

“We sought a re-examination of the CHMP opinion, and made the commitment to conduct a new post-approval confirmatory study, given the limited late-line treatment options available for EU patients living with chronic GVHD and the body of Rezurock clinical evidence generated including data from patients in Europe,” said Olivier Charmeil, Executive Vice President, General Medicines, Sanofi. “We remain committed to supporting the GVHD community and welcome this positive CHMP opinion, which brings us closer to delivering a new approved treatment in the EU for adult and adolescent GVHD patients who are waiting.”

Note that this is based on safety and efficacy results from several clinical studies and real-world evidence, including the randomised, multicentre ROCKstar phase 2 study, which demonstrated clinically meaningful and durable responses with Rezurock for 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 CHMP positive opinion for conditional marketing authorisation, Sanofi will also conduct a confirmatory randomised controlled study.

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Related Topics and Keywords

chmp approval, chronic graft, chronic graft-vs-host disease, host disease, rezurock, Sanofi’s Rezurock