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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a favorable opinion for the conditional marketing of Rezurock (belumosudil) “for the treatment of adults and children aged 12 years and over weighing at least 40 kg with chronic graft-versus-host disease (GVHD)”he specifies.
The drug should be used when other therapeutic options offer limited clinical benefit, are not adequate, or have been exhausted.
This positive recommendation follows Sanofi‘s request for review of the previous negative opinion adopted by the CHMP in October 2025, the group recalls. The final decision from the European Commission is expected in the coming weeks.
Already approved in 20 countries
GVHD is a life-threatening complication that can occur after stem cell transplantation (or allogeneic hematopoietic stem cell transplantation) when donor (graft) cells attack host cells, leading to inflammation and fibrosis that can damage multiple tissues and organs.
This disease is considered one of the leading causes of morbidity and late mortality without relapse after stem cell transplantation.
Currently, Rezurock is approved in 20 countries, including the United States, United Kingdom and Canada, for the treatment of patients aged 12 and older with chronic GVHD after previous therapies have failed.
https://www.whatsupdoc-lemag.fr/article/traitement-de-leczema-resultats-encourageants-pour-lamlitelimab-de-sanofi
“For patients who have already exhausted available treatment options, this favorable opinion marks an important step in our ability to better treat this complex disease”declared Mohamad Mohty, professor of hematology, head of the hematology and cellular therapy department at Saint-Antoine hospital and Sorbonne University, quoted in the press release.
With AFP