The CHMP committee of the European Medicines Agency (EMA) issued a positive opinion recommending the approval of Dupixent (dupilumab) from Sanofi and Regeneron in the EU.[1][3] This recommendation applies to the treatment of moderate to severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years.[1][3][4] The treatment is intended for patients who do not respond sufficiently to H1 antihistamines and have not yet had anti-IgE therapy.[1][4] If approved by the European Commission, Dupixent would become the first targeted medicine in the EU for children of this age with CSU.[1][3] A final decision is expected in the coming months.[1][2] CSU is a chronic skin disease with type 2 inflammation that causes debilitating hives and itching.[1] Dupixent is already approved in the EU for other indications and is used by more than 1.4 million patients worldwide.[1]