The European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged two to 11 years who do not respond adequately to histamine-1 antihistamines. The decision expands the drug’s existing approval in the European Union, which previously covered adults and adolescents aged 12 years and above.

Chronic spontaneous urticaria is a debilitating inflammatory skin condition characterised by recurring hives and intense itching, often significantly affecting patients’ quality of life. Treatment options for young children have historically been limited, leaving many with poorly controlled symptoms.

The approval is supported by data from the LIBERTY-CUPID phase III clinical programme, including the CUPIDKids study, which evaluated the safety, efficacy and pharmacokinetics of Dupixent in paediatric patients. Findings from the trials showed that the drug significantly reduced disease activity, including itch and hive severity and improved rates of well-controlled disease and complete response at 24 weeks compared to placebo.

Developed jointly by Sanofi and Regeneron, Dupixent works by inhibiting the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways—key drivers of type II inflammation. The therapy is administered via subcutaneous injection, with dosing tailored according to the patient’s age and weight.

Safety outcomes observed in the studies were consistent with the drug’s established profile across its approved dermatological indications. Common side effects include injection site reactions, conjunctivitis and mild infections, with similar safety findings reported in paediatric and adult populations.

The approval marks a significant milestone in paediatric dermatology, positioning Dupixent as the first targeted therapy for young children with CSU in the EU. The move is expected to address a critical unmet need and improve disease management for a vulnerable patient population.

Regulatory review is also underway in other regions, including the United States, where an application for paediatric use has been accepted for evaluation.