Sanofi Secures FDA Approval of Dupixent for Allergic Fungal Rhinosinusitis
FDA has approved Dupixent for adults and pediatric patients aged six and older with allergic fungal rhinosinusitis who have undergone sino-nasal surgery, marking the ninth FDA endorsement for the IL-4/IL-13 antibody. The decision, backed by the LIBERTY-AFRS-AIMS phase 3 trial, expands Sanofi’s sino-nasal disease franchise.
1. FDA Approval Expansion
FDA approval of Dupixent for allergic fungal rhinosinusitis in adults and pediatric patients aged six and older with history of sino-nasal surgery expands its label beyond chronic rhinosinusitis with nasal polyps.
2. Clinical Evidence
Approval is based on the LIBERTY-AFRS-AIMS phase 3 trial demonstrating efficacy and safety of dupilumab in treating AFRS, reinforcing its mechanism targeting IL-4 and IL-13–driven type 2 inflammation.
3. Strategic Implications
This ninth FDA nod for Dupixent strengthens Sanofi’s collaboration with Regeneron, broadens its sino-nasal disease portfolio, and opens a potentially underserved market segment that could boost franchise revenue.