Sanofi and Regeneron's Dupixent Gains FDA Approval for AFRS Treatment

Sanofi and Regeneron have announced that Dupixent (dupilumab) is now approved by the FDA for treating allergic fungal rhinosinusitis (AFRS) in individuals aged six and older. This marks Dupixent as the first medicine approved for AFRS, a type 2 inflammatory disease of the sinuses, often requiring surgery with high recurrence rates. The approval follows a phase 3 study showing significant improvements in sinus opacification, nasal congestion, and reduced need for corticosteroids or surgery.

AFRS is prevalent in warm, humid climates where fungal spores thrive, leading to nasal polyps and serious complications like bone erosion. Dupixent's unique ability to reduce symptoms by targeting IL4 and IL13 pathways sets a new standard of care for AFRS patients. The drug is administered via subcutaneous injection based on age and weight, offering a less burdensome treatment alternative to surgery and extended steroid use.

This FDA approval reinforces Dupixent's position as a versatile medication for a wide range of diseases involving type 2 inflammation. Sanofi and Regeneron plan to seek additional global approvals to broaden patient access.