Rezurock® now covered in Quebec for people living with chronic graft-versus-host disease (GVHD)

• Rezurock® (belumosudil tablets) now listed for public reimbursement, offering access to adult and pediatric patients 12 years and older with chronic GVHD after failure of at least two prior lines of systemic therapy
• A critical step following Health Canada approval (March 2023), Canada's Drug Agency (CDA-AMC) recommendation in March 2024, and Institute of Excellence in Health and Social Services (INESSS) recommendation in May 2024
• Chronic GVHD is a serious post-transplant complication affecting multiple organs including skin, mouth, eyes, joints, liver, lungs, and gastrointestinal tract, with significant impact on quality of life

TORONTO, Nov. 6, 2025 /CNW/ - Sanofi is pleased to announce that Quebec has added Rezurock® (belumosudil tablets) to the list of medications covered by the Régie de l'assurance maladie du Québec (RAMQ) for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.¹ The specific criteria for reimbursement is available on the RAMQ website.

Health Canada granted approval for Rezurock® for this indication in March 2023. Rezurock® received a Canada Drug Agency (CDA) recommendation for reimbursement by public drug plans on March 5, 2024, specifically for patients aged 12 years and older who have been clinically diagnosed with moderate to severe chronic GVHD, whose disease has not shown an adequate response to at least 2 prior lines of systemic therapy². Additionally, INESSS recommended Rezurock® for reimbursement with conditions on May 2, 2024. Full details on the reimbursement criteria are available on the CDA-AMC website and INESSS website.

Adele Fondeux  
General Manager, General Medicines, Sanofi

" Today's announcement brings hope to patients in Quebec living with chronic GVHD by providing access to an additional treatment option. For families facing this challenging post-transplant complication, public coverage makes treatment more accessible. We remain committed to working with provinces and territories to ensure patients across Canada have the same opportunity.

Dr . Christopher Lemieux, MD, FRCPC, DRCPC 
Hematologist-Oncologist, Director of the Cell Therapy Program,
CHU de Québec – Université Laval, Director of the Hematology Residency Program, Université Laval

" Chronic graft-versus-host disease affects multiple organs and can profoundly impact patients' quality of life. This milestone for Rezurock® brings renewed hope to patients and families who've faced limited treatment options for too long. Making innovative therapies available to Quebec patients with severe symptoms represents not just progress, but a meaningful path forward for managing this challenging condition ."    

Chronic GVHD is a complication that can occur following allogeneic stem cell transplantation, resulting in significant morbidity and mortality.[3] In chronic GVHD, transplanted immune cells (graft) attack the patient's cells (host), leading to inflammation and fibrosis in multiple tissues, including skin, mouth, eye, joint, liver, lung, esophagus and gastrointestinal tract.^3-5

About Rezurock®
Rezurock® is an inhibitor of Rho-associated, coiled-coil containing protein kinase-2 (ROCK2) and ROCK1, with IC₅₀ values of approximately 100 nM and 3 μM, respectively. Belumosudil downregulated proinflammatory responses via modulation of CD4+ T-cell activity and STAT3/STAT5 phosphorylation in ex vivo or in vitro human T cell assays. Belumosudil also inhibited pro-fibrotic signaling in vitro. In vivo, Rezurock® demonstrated activity in animal models of chronic GVHD.¹

About Sanofi

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more.

Sanofi is the largest biopharma manufacturer in Canada, and the only company investing, innovating and operating across the full life sciences value chain. We are 2,000+ employees strong, invest 20% of our revenue annually in biopharma research, and are on track to deliver over $2 billion in new infrastructure investments by 2028. Sanofi is committed to our community and is working with partners to foster a long-term sustainable ecosystem and build a healthier Canada.

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1 Rezurock® Product Monograph, June 28, 2024

2 https://www.cda-amc.ca/sites/default/files/DRR/2024/SR0789%20Rezurock%20-%20Confidential%20Final.pdf

3 Leukemia & Lymphoma Society of Canada. Graft-Versus-Host Disease. Available at: 201816-GVHD-gatefold-EN-WEB.pdf

⁴ Canadian Cancer Society. Graft-Versus-Host Disease. Available at: https://cancer.ca/en/treatments/side-effects/graft-versus-host-disease-gvhd#:~:text=Graft%2Dversus%2Dhost%2Ddisease,identify%20and%20destroy%20cancer%20cells. Accessed November 5, 2025.

⁵ Kitko CL, White ES, Baird K. Fibrotic and sclerotic manifestations of chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2012 Jan; 18(1 Suppl): S46-52. doi: 10.1016/j.bbmt.2011.10.021. PMID: 22226112; PMCID: PMC3260451.

SOURCE Sanofi-Aventis Canada Inc.

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