Dupixent Nears Ninth FDA Approval for Treating Allergic Fungal Rhinosinusitis

Sanofi and Regeneron’s Dupixent (dupilumab) is poised for its ninth U.S. approval after demonstrating strong efficacy in a Phase III trial for allergic fungal rhinosinusitis (AFRS). In the LIBERTY-AFRS-AIMS study, Dupixent achieved a 50% improvement in sinus opacification versus 9.8% with placebo at 52 weeks, meeting the primary endpoint. Patient-reported nasal congestion improved by 66.7% at 24 weeks and 80.6% at 52 weeks, compared with 25.3% and 11.1% in the placebo group. Nasal polyp size decreased by over 60%, and the risk of systemic corticosteroid use or surgery dropped by 92%.

The trial marks the first successful Phase III study for AFRS, highlighting IL-4 and IL-13 as major drivers of type 2 inflammation in the condition. The FDA has granted priority review for Dupixent’s supplemental biologics license application, which could make AFRS its ninth approved indication. Dupixent generated $14.15 billion in global sales in 2024.

11-11-2025