Positive Topline Results Shown for Dupilumab in Phase 3 Trials in Patients with CRSwNP – APhA submits compounding comments to FDA. – (866) 348-2889.
All primary and secondary endpoints were met in a pair of pivotal Phase 3 placebo-controlled trials that evaluated Sanofi and Regeneron’s dupilumab product (Dupixent®) for adults with inadequately-controlled chronic rhinosinusitis with nasal polyps (CRSwNP).1
On the coprimary endpoints for both trials at 24 weeks, patients treated with dupilumab added to a standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement in their nasal congestion/obstruction severity compared to 15% and 19% improvement with nasal spray alone (placebo) (-1.25 and -1.34 for dupilumab compared to -0.38 and -0.45 for placebo, on a 0-3 scale ). Dupilumab treated patients had a 27% and 33% reduction in their nasal polyps score compared to a 4% and 7% increase for placebo (-1.71 and -1.89 for dupilumab compared to 0.10 and 0.17 for placebo, on a 0-8 scale that measures bilateral polyps size by endoscopy).1