DUPIXENT® (dupilumab injection) is now Approved in Canada for the Treatment of Adult and Adolescent Patients (12+) With Eosinophilic Esophagitis
- This is the eighth indication for DUPIXENT® in Canada and its first in gastroenterology.
MISSISSAUGA, ON — /CNW/ — sanofi-aventis Canada Inc. (Sanofi Canada) is pleased to announce that Health Canada has issued a Notice of Compliance for DUPIXENT® (dupilumab injection) for the treatment of patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).1
EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.2
Dr. Christopher Ma, MD, FRCPC
Clinical Assistant Professor of Medicine
“As the first biologic therapy approved for the management of active eosinophilic esophagitis, the approval of DUPIXENT® marks a watershed moment for our patients living with eosinophilic esophagitis in Canada. Having an effective treatment that not only reduces histologic inflammation, but also improves symptoms by targeting type 2 inflammation, revolutionizes our therapeutic armamentarium and will improve the quality of life of our patients.”
Dr. Natacha Tardio, MD, FRCPC
Assistant Professor of Medicine, Co-director of the Multi-Disciplinary EoE Clinic, Division of Clinical Immunology and Allergy, McGill University Health Centre.
“DUPIXENT® has shown to be an important treatment option for the management of atopic disorders including asthma, atopic dermatitis and recently, eosinophilic esophagitis (EoE). As the first biologic treatment option for adults suffering from EoE, it creates a promising opportunity to significantly improve the lives of patients with this chronic condition.”
Immunology Franchise Head at Sanofi Canada
“At Sanofi, we are dedicated to addressing the unmet medical needs of patients suffering from the debilitating effects of type 2 inflammatory diseases, including EoE. This approval for DUPIXENT® represents an advancement for adults and adolescents in Canada suffering from the chronic and often debilitating symptoms of EoE.”
The DUPIXENT® product monograph includes data from the Phase 3 LIBERTY-EoE-TREET trial, consisting of Parts A and B. Part A and Part B investigated DUPIXENT® 300 mg weekly (Part A n=42; Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24 weeks. Please refer to the product monograph for more information.
DUPIXENT® is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.
DUPIXENT® was first approved in Canada in 2017 for the treatment of adults with moderate-to-severe atopic dermatitis. DUPIXENT® has since been approved for the treatment of adolescents, children and infants aged 6 months and older with moderate-to-severe atopic dermatitis; adults with chronic rhinosinusitis with nasal polyposis (CRSwNP); adults, adolescents, and children aged six years and older with severe asthma; and now adults and adolescents aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE).
DUPIXENT® is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In Canada, DUPIXENT® is jointly commercialized by Sanofi Canada and Regeneron Canada.
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For more information about DUPIXENT®, please refer to the Canadian Product Monograph. https://products.sanofi.ca/en/dupixent-en.pdf
DUPIXENT® and Sanofi are trademarks of Sanofi, used under license by sanofi-aventis Canada Inc.
1 DUPIXENT® Product Monograph, May 1, 2023.
2 Canadian Digestive Health Foundation. Eosinophilic Esophagitis. Available at: https://cdhf.ca/en/digestive-conditions/eosinophilic-esophagitis/ April 11, 2023.
SOURCE Sanofi Canada
Original source here.