Health
Dupixent® (dupilumab) Pivotal Trial Met All Primary and Secondary Endpoints, Reducing Signs and Symptoms of Allergic Fungal Rhinosinusitis (AFRS); sBLA Accepted for FDA Priority Review
Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal congestion and nasal polyps in patients aged 6 years and older compared to placebo Dupixent sBLA accepted for priority review by the U.S. FDA with a target action date of February 28, 2026 If approved, Dupixent would be the first and only medicine indicated specifically for AFRS, which would be its ninth FDA-approved indication AFRS is a chronic type
About this update from Sanofi Sa
[{"type":"image","alt":"Regeneron Pharmaceuticals, Inc.","displaySize":"","headline":null,"caption":"Regeneron Pharmaceuticals, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":47,"url":"https://media.zenfs.com/en/globenewswire.com/dd48a84a10e2c569a1750589118f2d19"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/OMbrbjdR7YYzdW3N_PREZQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTY2O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/dd48a84a10e2c569a1750589118f2d19","width":300,"height":47}},"lazy":false},{"type":"text","content":"Phase 3 data to be presented at ACAAI demonstrate Dupixent significantly reduced key nasal signs and symptoms including sinus opacification, nasal congestion and nasal polyps in patients aged 6 years and older compared to placebo","length":229,"tagName":"p"},{"type":"text","content":"Dupixent sBLA accepted for priority review by the U.S. FDA with a target action date of February 28, 2026","length":110,"tagName":"p"},{"type":"text","content":"If approved, Dupixent would be the first and only medicine indicated specifically for AFRS, which would be its ninth FDA-approved indication","length":140,"tagName":"p"},{"type":"text","content":"AFRS is a chronic type 2 inflammatory disease of the sinuses characterized by a fungal hypersensitivity ","length":103,"tagName":"p"},{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, Nov. 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the presentation of positive results from the pivotal LIBERTY-AFRS-AIMS Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS). The trial demonstrated significant improvements in signs and symptoms of disease across all primary and secondary endpoints, including reductions in sinus opacification, nasal congestion and nasal polyps compared to placebo. These are the first-ever positive Phase 3 results specifically in AFRS and will be shared today at the American College of Allergy, Asthma and Immunology (ACAAI) 2025 Annual Scientific Meeting.","length":789,"tagName":"p"},{"type":"text","content":"Recently, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent in adults and ch...