Globenewswire·2025-11-07 13:00Core Insights - The pivotal LIBERTY-AFRS-AIMS phase 3 study of Dupixent (dupilumab) showed significant improvements in allergic fungal rhinosinusitis (AFRS) symptoms, meeting all primary and secondary endpoints [1][5][6] - The FDA has accepted the supplemental biologics license application (sBLA) for Dupixent in treating AFRS, which could become its ninth approved indication [2][5] Study Results - The study demonstrated a 50.0% improvement in sinus opacification scores for Dupixent compared to 9.8% for placebo at 52 weeks, with a significant reduction observed at 24 weeks [6] - Patient-reported nasal congestion improved by 66.7% at 24 weeks and 80.6% at 52 weeks in the Dupixent group compared to 25.3% and 11.1% in the placebo group, respectively [6][13] - Nasal polyp size reduced by 60.8% at 24 weeks and 62.5% at 52 weeks in the Dupixent group compared to 15.2% and 3.6% in the placebo group [13] Safety Profile - The overall rates of adverse events were 70% for Dupixent and 79% for placebo, with serious adverse events reported in 0% of Dupixent patients compared to 7% for placebo [7] - Common treatment-emergent adverse events included COVID-19 and nosebleeds, with similar rates between Dupixent and placebo [7] Background on AFRS - AFRS is a chronic type 2 inflammatory disease of the sinuses caused by allergic hypersensitivity to fungi, primarily affecting individuals in warm, humid climates [3][5] - Current treatment options are limited, often involving surgery and prolonged systemic steroids, with a high rate of disease recurrence [3][4] Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL4 and IL13 signaling pathways, showing significant clinical benefits in various type 2 inflammatory diseases [10][11] - The drug has received regulatory approvals in over 60 countries for multiple indications, with more than one million patients treated globally [11][12]