DUPIXENT (dupilumab injection) is now approved in Canada for the treatment of adult and adolescent patients (12+) with Eosinophilic Esophagitis

2023-05-04

上市批准临床3期引进/卖出疫苗

* This is the eighth indication for DUPIXENT® in Canada and its first in gastroenterology. MISSISSAUGA, ON, May 4, 2023 /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." James Guy 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. About DUPIXENT® 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. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. In Canada, Sanofi employs approximately 2,000 people and in 2020, we invested more than $145 million in R&D in Canada, creating jobs, business and opportunity throughout the country. Follow us on Twitter @SanofiCanada For more information about DUPIXENT®, please refer to the Canadian Product Monograph. DUPIXENT® and Sanofi are trademarks of Sanofi, used under license by sanofi-aventis Canada Inc. SOURCE Sanofi Canada