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 not responded adequately to standard antihistamine treatment [1][2]. Group 1: Approval and Clinical Studies - The positive CHMP 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 with CSU [2]. - Dupixent is already approved for CSU in certain adults and adolescents in multiple jurisdictions, including the US, EU, and Japan [2]. Group 2: Regulatory Developments - 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 from the FDA expected by April 2026 [3]. Group 3: Disease Background - 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 significant impacts on their quality of life due to uncontrolled symptoms [5]. Group 4: 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 Dupixent development program has demonstrated significant clinical benefits and a reduction in type 2 inflammation in phase 3 studies [6]. Group 5: Market Presence - Dupixent has received regulatory approvals in over 60 countries for various indications, including atopic dermatitis, asthma, and CSU, with more than 1.4 million patients currently treated globally [7][8].