Posted by Michael Wonder on 21 Sep 2019
CHMP recommends approval of Dupixent (dupilumab) for severe chronic rhinosinusitis with nasal polyposis
20 September 2019 - The EMA’s CHMP has adopted a positive opinion for Dupixent®(dupilumab) in a third indication.
The CHMP recommended Dupixent be approved as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. If approved, Dupixent would be the first biologic medicine available in the European Union to treat these patients.
The positive CHMP opinion 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. A final decision on the Dupixent application by the European Commission is expected in the coming months.
