First Targeted CSU Therapy for Children Gets Nod from European Commission
The European Commission has approved dupilumab (Dupixent) as the first targeted therapy for chronic spontaneous urticaria (CSU) in children in the EU, broadening its use in type‑2‑driven inflammatory diseases.
Dupilumab (Regeneron and Sanofi’s Dupixent) has been approved in the European Union for children aged 2–11 years with moderate‑to‑severe CSU, becoming the first targeted medicine for this age group in the region. The European Commission’s decision extends dupilumab’s existing CSU indication — which previously covered only adults and adolescents aged 12 years and older — down into early childhood and elementary‑school age (1).
CSU is a long‑term skin condition in which the immune system becomes abnormally activated, leading to recurrent, itchy hives that appear and disappear over at least six weeks, often without an obvious trigger (1,2). CSU is increasingly recognized as a type‑2 inflammatory condition driven by IL‑4/IL‑13‑mediated pathways, and although the cause is not clearly identifiable, evidence suggests an autoimmune component in about half of cases, with autoantibodies mistakenly activating mast cells and driving inflammation. For children, these unpredictable flare‑ups can disrupt sleep, school, play, and social interactions, making a targeted, reliable treatment option particularly important.
The updated EU approval is based on data from the LIBERTY‑CUPID clinical trial program, including efficacy extrapolation from the adult Phase III trials and results from the CUPIDKids single‑arm Phase III study in children aged 2–11 years with CSU. In CUPIDKids, Dupixent showed clinically meaningful reductions in itch and hives while maintaining a safety profile consistent with its established profile across other age groups and indications. Authorization of the drug is granted to children with moderate‑to‑severe CSU who remain inadequately controlled on standard‑of‑care H1 antihistamines and are naïve to anti‑immunoglobulin E (anti‑IgE) therapy.
“Young children suffering from chronic spontaneous urticaria often experience an unpredictable barrage of unrelenting itch and visible hives during the critical years of their growth and development. As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent, in a company press release (1).
Beyond CSU, dupilumab is approved for moderate‑to‑severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, bullous pemphigoid, and certain COPD cases, where it similarly dampens type‑2 inflammation to improve skin, respiratory, and mucosal symptoms. Delivered as a subcutaneous injection every two or four weeks, dupilumab is used as an add‑on or maintenance therapy when conventional treatments fail to provide adequate control (3). The approval places the drug at the center of a growing portfolio of IL‑4/IL‑13‑targeted therapies across multiple allergic and inflammatory diseases.
References
Regeneron. Dupixent (dupilumab) Approved in the EU as the First Targeted Medicine to Treat Young Children with Chronic Spontaneous Urticaria (CSU). News release, April 13, 2026.
Allergy UK. Chronic Spontaneous Urticaria (CSU). allergyuk.org (accessed April 15, 2026).
Dupixent. Take Action With DUPIXENT (dupilumab). Dupixent.com (accessed April 15, 2026).