FDA approves Dupixent for allergic fungal rhinosinusitis

The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) and a history of sino-nasal surgery.

Dupixent received priority review for AFRS, because AFRS may not respond well to available options. Current standard-of-care treatment includes surgery and prolonged courses of systemic steroids, with disease recurrence not uncommon.

The approval was based on the LIBERTY-AFRS-AIMS phase 3 trial, in which 62 participants with AFRS were randomly assigned to receive an age- and weight-based dose of Dupixent (200 mg or 300 mg) every two or four weeks (33 participants) or placebo (29 participants). Sinus opacification, assessed by computed tomography scans, improved by 50% with Dupixent compared with 10% with placebo at week 52, as well as week 24.

Additionally, patient-reported nasal congestion/obstruction improved by 67% versus 25% at week 24, with continued improvement at week 52 (81 versus 11%). At both week 24 and week 52, nasal polyp size (assessed by endoscopy) was reduced by 61 versus 15% and 63 versus 4%, respectively. Other benefits included reductions in patient-reported loss of smell (67 versus 19% at week 24) and reduced treatment burden (92% reduction in the risk for systemic corticosteroid use and/or need of surgery).

“Beyond reducing nasal signs and symptoms, Dupixent reduced the need for surgery or systemic corticosteroids, with fewer patients having bone erosion in the sinuses,” George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron, said in a statement. “These results underscore its potential to establish a new standard of care for people living with AFRS.”

This approval of Dupixent was granted to Regeneron.

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