Posted by Michael Wonder on 19 Aug 2020
Dupixent (dupilumab injection) now approved by Health Canada for severe chronic rhinosinusitis with nasal polyposis
18 August 2020 - First biologic approved in Canada for adults with severe chronic rhinosinusitis with nasal polyposis.
Sanofi Canada announced today that Health Canada approved a new indication for Dupixent (dupilumab injection), as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyposis inadequately controlled by systemic corticosteroids and/or surgery, making it the first biologic for the treatment of this disease in Canada.
The Health Canada approval is based on two pivotal Phase 3 trials (the 24 week SINUS-24 and 52 week SINUS-52) that evaluated Dupixent 300 mg every two weeks plus standard care intranasal corticosteroids compared to placebo plus intranasal corticosteroids.
