Dupixent (dupilumab injection) now approved in Canada for the treatment of severe asthma in children aged six to 11 years with type 2 inflammation
MISSISSAUGA, ON, March 28, 2022 /CNW/ - Today Sanofi-Aventis (Canada) Inc. (Sanofi Canada) announced the expanded approval of Dupixent® (dupilumab injection) as an add-on maintenance treatment in patients aged six to 11 years with severe asthma with a type 2 / eosinophilic phenotype or oral corticosteroid-dependent asthma. The approval is based on the pivotal VOYAGE phase 3 trial which enrolled 408 children aged six to 11 years with uncontrolled moderate- to severe asthma. The primary endpoint of the trial was the annualized rate of severe asthma exacerbationsii.
Reza Alizadehfar, MD FRCPC
Sixth indication for Dupixent, its second in asthma, and its second indication in children aged six to 11 years
Dupixent was first approved in Canada in 2017 for the treatment of adults with atopic dermatitis. Dupixent has since been approved for the treatment of adolescents and children aged six and older with atopic dermatitis; adults with chronic rhinosinusitis with nasal polyposis (CRSwNP); and adults, adolescents and now children aged six and older with severe asthma. Dupixent is the first medicine approved for the treatment of severe asthma with a type 2 inflammation phenotype. More than 8,500 Canadians have been treated with Dupixent across its various indications.
Eric Trottier, PhD
Asthma is a chronic inflammatory disease of the airways that causes symptoms like shortness of breath, chest tightness, coughing and wheezing. Asthma causes inflammation and narrowing of the bronchial tubes, which leads to limited airflow and difficulty breathingiii. People with severe asthma experience difficulty breathing, coughing, wheezing, and are at risk for life-threatening asthma attacks, which may require visits to the emergency room or hospitalizationiv,v. Some people with severe asthma can manage their symptoms with inhaled corticosteroids, while other people require different or additional kinds of medicine to manage their disease.
Asthma is the third-most common chronic disease among Canadiansvi,vii, and the most common chronic disease in Canadian children: 15% - 25% of Canadian children are diagnosed with asthmaviii.
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. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in severe asthma, atopic dermatitis, and chronic rhinosinusitis with nasal polyposis (CRSwNP).
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 Company.
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.
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® Dupixent is a registered trademark owned by Sanofi Biotechnology and used under license.
i Dupixent product monograph March 25, 2022
SOURCE Sanofi-Aventis Canada Inc.
Company Codes: EuronextParis:SAN, NASDAQ-NMS:SNY