FDA Reviews Dupixent After Breakthrough AFRS Trial Success

Dupixent, developed by Sanofi and Regeneron, continues to expand its reach across multiple type 2 inflammatory diseases, with over one million patients treated globally.

Positive results from the pivotal LIBERTY-AFRS-AIMS Phase 3 trial reveal that Dupixent considerably enhanced symptoms in adults and children aged six years and older with allergic fungal rhinosinusitis (AFRS).

The investigational treatment met all primary and secondary endpoints, marking the first-ever positive Phase 3 results explicitly for AFRS. Data will be presented at the ACAAI 2025 Annual Scientific Meeting in Orlando, Florida.

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The FDA has accepted a priority review for Dupixent’s supplemental biologics license application in AFRS, recognizing its potential to improve outcomes for these difficult-to-treat chronic type 2 inflammatory diseases. If approved, AFRS would become the ninth FDA-approved indication for Dupixent.

AFRS is caused by an allergic hypersensitivity to fungi, often leading to nasal polyps, congestion, and facial deformities. Current treatment typically involves surgery and long-term steroid use, with frequent relapses.

According to Dr. Amber U. Luong, lead investigator of the study, Dupixent’s results are groundbreaking: “People with allergic fungal rhinosinusitis live with persistent nasal obstruction, congestion, and polyps that can place a great strain on their day-to-day lives. With limited treatment options, uncontrolled symptoms can progress to serious complications like the buildup of thick mucus that may require surgery, bony erosion of the sinuses, and facial deformities.”

In the study, Dupixent delivered a 50% improvement in sinus opacification, over 60% reduction in nasal polyps, and a 92% lower need for surgery or corticosteroids compared to placebo. Safety outcomes were consistent with its known profile.