Press Release: Sanofi and Regeneron's Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis

Core Insights - The FDA has approved Dupixent (dupilumab) as the first and only treatment for allergic fungal rhinosinusitis (AFRS) in patients aged 6 years and older with a history of sino-nasal surgery, marking a significant advancement in the treatment of this chronic condition [2][4][9] Group 1: Approval and Indications - Dupixent is now approved for treating nine distinct diseases driven by type 2 inflammation, including sino-nasal, skin, gut, and respiratory diseases [6] - The approval was based on the LIBERTY-AFRS-AIMS phase 3 study, which demonstrated significant improvements in sinus opacification scores and nasal symptoms compared to placebo [4][10] Group 2: Disease Overview - Allergic fungal rhinosinusitis (AFRS) is characterized by chronic inflammation of the nasal passages due to an allergic reaction to fungi, leading to symptoms such as nasal congestion, loss of smell, and potential complications like bone erosion [3][6] - The condition is particularly prevalent in warm, humid climates where fungal spores are abundant [3] Group 3: Clinical Study Results - In the LIBERTY-AFRS-AIMS study, Dupixent showed a 50% improvement in sinus opacification scores at Week 52 compared to a 10% improvement in the placebo group [4][11] - Patient-reported nasal congestion improved by 67% at Week 24 and 81% at Week 52 with Dupixent, compared to 25% and 11% in the placebo group, respectively [7][13] Group 4: Treatment Benefits - Dupixent reduced the need for systemic corticosteroids and surgeries by 92%, with only 3% of patients on Dupixent requiring these interventions compared to 31% on placebo [13] - The treatment also significantly reduced nasal polyp size and improved the sense of smell in patients [13][15] Group 5: Safety Profile - The safety profile of Dupixent in the LIBERTY-AFRS-AIMS study was consistent with its known safety profile in chronic rhinosinusitis with nasal polyps, with common adverse reactions including injection site reactions and conjunctivitis [8][9] Group 6: Future Developments - Sanofi and Regeneron plan to submit additional applications to regulatory authorities worldwide to expand access to Dupixent for patients in need [9][17] - The Dupilumab development program has involved over 60 clinical studies with more than 12,000 patients, indicating a strong commitment to addressing various diseases driven by type 2 inflammation [18][19]