Globenewswire·2026-02-27 12:03Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab) for treating chronic spontaneous urticaria (CSU) in children aged two to 11 years who have moderate-to-severe symptoms despite treatment with antihistamines [1][2]. Group 1: Product Approval and Clinical Studies - Dupixent's positive opinion is based on data from the LIBERTY-CUPID clinical study program, which includes two phase 3 studies and a single-arm phase 3 study involving children aged two to 11 years [2]. - In the US, a supplemental biologics license application for Dupixent in children aged two to 11 years with CSU has been accepted for review, with a decision expected by April 2026 [3]. Group 2: Disease Background and Treatment Options - Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease characterized by debilitating hives and recurring itch, often inadequately controlled by standard antihistamine treatments [5]. - Many patients with CSU experience uncontrolled symptoms despite treatment, leading to a significant impact on their quality of life [5]. Group 3: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 (IL4) and interleukin-13 (IL13) signaling pathways, which are key drivers of type 2 inflammation [6]. - The drug has received regulatory approvals in over 60 countries for various indications, including CSU, and is currently being used to treat more than 1.4 million patients globally [7]. Group 4: Development and Future Prospects - Dupilumab is being jointly developed by Sanofi and Regeneron, with over 60 clinical studies involving more than 12,000 patients conducted to date [8]. - Sanofi and Regeneron are exploring additional indications for Dupixent, including chronic pruritus of unknown origin and lichen simplex chronicus, which are currently under clinical investigation [9].