Dupixent Approved in the U.S. as First Targeted Therapy for Allergic Fungal Rhinosinusitis

Regeneron Pharmaceuticals and Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of allergic fungal rhinosinusitis (AFRS) in adults and children aged six years and older with a history of sino-nasal surgery. The approval makes Dupixent the first and only medicine specifically indicated for this chronic inflammatory sinus disease, supported by Phase 3 trial data showing significant reductions in nasal symptoms as well as decreased need for systemic corticosteroids or repeat surgeries.

Advancing Treatment for a Difficult Sinus Disease

AFRS is a severe subtype of chronic rhinosinusitis driven by allergic hypersensitivity to fungi and often associated with recurrent nasal polyps, congestion, and loss of smell. Existing treatment options largely rely on surgery and long-term steroid use, with frequent disease recurrence. Dupixent’s targeted inhibition of IL-4 and IL-13 pathways addresses underlying type 2 inflammation, offering a disease-modifying approach rather than symptom control alone.

Strengthening Dupixent’s Immunology Franchise

This approval marks another expansion of Dupixent’s growing portfolio across type 2 inflammatory diseases, reinforcing its position as a cornerstone biologic in immunology. With approvals now spanning multiple dermatologic, respiratory, and gastrointestinal conditions, the therapy continues to demonstrate commercial and clinical momentum, supporting Regeneron and Sanofi’s strategy of broad lifecycle expansion through new indications targeting shared inflammatory pathways.