FDA

FDA approves Dupixent for allergic fungal rhinosinusitis

February 27, 2026

On February 24, 2026, FDA approved Dupixent (dupilumab) for the treatment of allergic fungal rhinosinusitis (AFRS) in adult and pediatric patients ≥6 years of age with a history of sinonasal surgery. This is the first FDA-approved medication for AFRS, a chronic rhinosinusitis subtype associated with frequent postsurgical recurrence and long‑term systemic corticosteroid use.

Efficacy

Efficacy was evaluated in the randomized, double-blind, parallel-group, placebo-controlled LIBERTY-AFRS-AIMS trial (NCT04684524). Patients ≥6 years of age with AFRS were eligible to enroll if they had sinus opacification on the Lund‑Mackay (LMK) sinus CT scan, defined as an LMK score ≥9 for unilateral polyps and >12 for bilateral polyps, and also had a nasal polyps score ≥2 for unilateral polyps or ≥3 for bilateral polyps. Subjects were randomized 1:1 to receive either Dupixent or placebo subcutaneously for 52 weeks.

The primary endpoint was change from baseline in sinus opacification assessed by the LMK sinus CT scan score at week 52. Patients treated with Dupixent demonstrated a 50% improvement in sinus opacification scores compared with 10% in the placebo group (7.36-point placebo-corrected reduction; p<0.0001) at week 52. Significant improvement in sinus opacification at week 24, a secondary endpoint, was also demonstrated (p<0.0001).

Additional measures — including nasal polyp size, nasal congestion, and sense of smell — also showed significant improvements with Dupixent compared with placebo. Nasal polyp size decreased at week 24 (p<0.0001), with greater reduction by week 52 (2.77‑point placebo‑corrected reduction; p<0.0001). Patient‑reported nasal congestion/obstruction improved at week 24 (p< 0.0001), and continued to improve at week 52 (1.40‑point placebo‑corrected reduction; p<0.0001). Loss of smell was also reduced at week 24 (0.89‑point placebo‑corrected reduction; p< 0.0001).

Over 52 weeks, Dupixent reduced the need for systemic corticosteroids and sinus surgery and lessened sinus bone erosion, a serious complication of AFRS.

Safety

The safety profile of Dupixent in AFRS patients is similar to what's been observed in patients with chronic rhinosinusitis with nasal polyps, both in clinical trials and post-market setting. The most common adverse reactions (≥1% and greater than placebo) were injection site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache.

Sources:

FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-adult-and-pediatric-patients-aged-6-and-older-allergic-fungal-rhinosinusitis

Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis. [News release]. 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-24-14-30-00-3243732

Dupixent (dupilumab) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s075lbl.pdf Revised February 2026. Accessed February 26, 2026.