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Press Release: Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease
Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease Paris, October 17, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the marketing authorisation application for Rezurock (belumosudil) for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD). Sanofi will seek a re-examination of the CHMP opinion. cGVHD is a life-th
About this update from Sanofi Sa
[{"type":"image","alt":"Sanofi Winthrop Industrie","displaySize":"","headline":null,"caption":"Sanofi Winthrop Industrie","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":84,"url":"https://media.zenfs.com/en/globenewswire.com/c45c40f5ed741dd9c0f5c2f75b8fc137"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/njIuMc8eT.GfUOY8hGPCUA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/c45c40f5ed741dd9c0f5c2f75b8fc137","width":300,"height":84}},"lazy":false},{"type":"text","content":"Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease","length":105,"tagName":"p"},{"type":"text","content":"Paris, October 17, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the marketing authorisation application for Rezurock (belumosudil) for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD). Sanofi will seek a re-examination of the CHMP opinion.","length":375,"tagName":"p"},{"type":"text","content":"cGVHD is a life-threatening complication that devastates the lives of up to 50% of patients who undergo a stem cell transplant. cGVHD is considered one of the main causes of morbidity and late non-relapse mortality after stem cell transplant.","length":242,"tagName":"p"},{"type":"text","content":"“We are disappointed by the negative CHMP opinion for Rezurock in the EU and remain committed to serving the transplant patient community,” said Olivier Charmeil, Executive Vice President, General Medicines at Sanofi. “Sanofi is confident in the body of clinical and real-world evidence that underscores Rezurock’s consistent efficacy and well-established safety profile for treating third-line chronic graft-versus-host disease. We will continue to work closely with the European Medicines Agency with the aim of bringing this treatment to patients in the EU who are waiting.”","length":577,"tagName":"p"},{"type":"text","content":"Rezurock is supported by safety and efficacy results from several clinical studies and real-world evidence. This includes the randomized, multicenter ROCKstar phase 2 study, that demonstrates consistent efficacy and tolerability for patients living with cGVHD after stem cell transplant as well as durable c...