Overview
- The approval covers patients 6 years and older who have allergic fungal rhinosinusitis and a history of sino-nasal surgery.
- Support for the decision came from the randomized, double-blind, placebo-controlled LIBERTY-AFRS-AIMS trial that enrolled 62 participants and dosed dupilumab by weight over 52 weeks.
- At one year, CT-assessed sinus opacification improved by 50% with dupilumab versus 10% with placebo, with a significant benefit also seen at week 24.
- Patients on dupilumab reported greater relief in nasal congestion and loss of smell, and showed larger reductions in nasal polyp size at weeks 24 and 52 compared with placebo.
- Over 52 weeks, dupilumab cut the combined risk of systemic corticosteroid use or surgery by 92%, with a safety profile consistent with its use in chronic rhinosinusitis with nasal polyps.