Posted by Michael Wonder on 30 Oct 2019
Dupixent (dupilumab) now approved in European Union for severe chronic rhinosinusitis with nasal polyposis
29 October 2019 - First biologic approved in the European Union for adults with severe chronic rhinosinusitis with nasal polyposis.
The European Commission today approved a new indication for Dupixent (dupilumab) in chronic rhinosinusitis with nasal polyposis (CRSwNP). Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.
The 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-of-care intranasal corticosteroids compared to placebo plus intranasal corticosteroids.
