The European Medicines Agency (EMA) CHMP has issued a positive opinion recommending the approval of Sanofi and Regeneron's Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in children aged 2 to 11 years.[1][2][4] This recommendation applies to children with moderate to severe CSU in whom standard treatment with H1-type antihistamines is not sufficient and who have not yet been treated with anti-IgE therapy.[1][2] If approved, Dupixent would become the first targeted medicine in the EU for children aged 2 to 11 years with CSU unresponsive to antihistamines.[1][4] The final decision of the European Commission is expected in the coming months.[1][2] CSU is a chronic type 2 inflammatory skin disease that causes debilitating hives and recurrent itching in young children.[1] Dupixent is approved in the EU to expand the indication for the pediatric population younger than 12 years of age with this disease as first-line biologic therapy.[4]