FDA Approval of Dupixent (dupilumab) in adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis

发布时间： 2026-02-27 阅读：3次

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On February 26, 2026, The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery. This is the first approval for this condition.

Allergic fungal rhinosinusitis (AFRS) is an uncommon type of chronic sinus inflammation caused by an allergic reaction to fungi growing in the sinuses, with production of thick, sticky mucus often described as resembling peanut butter. AFRS affects up to 8% of people with chronic sinus inflammation and nasal polyps, is more common in warm, humid areas where fungi thrive, and typically begins in teenagers and young adults. If left untreated, AFRS can cause serious problems, including expansion of the sinuses, erosion of surrounding bone (in up to 90% of patients), and spread to the eye area or brain, leading to facial deformities, vision problems, and nerve damage.

Dupilumab's effectiveness and safety were evaluated in a 52-week study of adult and pediatric participants aged 6 years and older with AFRS. The study showed that dupilumab significantly improved sinus opacification compared to placebo, as measured by CT scan scores (Lund-Mackay score). Additional measures — including nasal polyp size, nasal congestion, and sense of smell — also showed significant improvement and supported the main findings. Dupilumab substantially reduced the need for systemic corticosteroids and sinus surgery compared to placebo over 52 weeks, which is particularly important given the severity of AFRS. The medication also reduced sinus bone erosion, a serious complication unique to AFRS.