By VETTAPHARMA reporter – Derek Roche: The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of allergic fungal rhinosinusitis (AFRS) in adults and pediatric patients aged 6 years and older with a history of sino-nasal surgery — marking the first and only FDA-approved medicine for this condition.
The approval is supported by data from the LIBERTY-AFRS-AIMS phase 3 study (clinical identifier: NCT04684524), in which 62 adults and children with AFRS were randomized to receive Dupixent (200 mg or 300 mg) every two or four weeks (n = 33) or placebo (n = 29).
Key outcomes from the trial included:
- Primary endpoint — sinus opacification improved by 50% with Dupixent versus 10% with placebo at Week 52 (p < 0.0001).
- Secondary endpoints showed greater improvement in nasal congestion (67% vs 25% at Week 24, and 81% vs 11% at Week *52), nasal polyp size reduction (61% vs 15% at Week *24, and 63% vs 4% up to Week *52), and reportable smell loss reduction (67% vs 19% at Week *24).
- Dupixent also led to a 92% reduction in the risk of systemic corticosteroid use or surgery over 52 weeks compared with placebo (with 3% vs 31% receiving steroids and 0% vs 7% undergoing surgery).
AFRS is a chronic type 2 inflammatory disease of the sinuses driven by allergic hypersensitivity to fungi, often severe, difficult to treat, and prone to recurrence after surgery. Prior to this approval, standard care typically involved surgery and prolonged systemic steroids, with high rates of post-operative recurrence.
With this FDA action, Dupixent’s approved indications in sino-nasal diseases now include AFRS alongside chronic rhinosinusitis with nasal polyps. The drug is now approved in the US for nine distinct diseases driven partly by type 2 inflammation and affects a broad range of patients from infants to elderly adults.
Dupixent has received regulatory approvals in more than 60 countries, and over 1.4 million patients are being treated with the medicine globally.
