Sanofi: Dupixent Receives European Green Light for Children as Young as 2 Years Old
The European Commission has approved Dupixent (dupilumab) for the treatment of moderate to severe spontaneous chronic urticaria in children aged two to 11 years. This approval extends the drug's indication, previously limited to adults and adolescents aged 12 and over in the European Union.
A First for Young Children in the EU
Dupixent becomes the first targeted medication approved in the EU to treat spontaneous chronic urticaria in young children. The approval specifically targets children who have shown an inadequate response to H1 antihistamines and have not previously received anti-immunoglobulin E (IgE) treatment. The drug, a fully human monoclonal antibody, inhibits the signaling pathways of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key factors in type 2 inflammation. The authorization is based on the LIBERTY-CUPID clinical study program, including efficacy and pharmacokinetic data from phase 3 studies in children and adolescents.
Dosage and Administration
Dupixent is administered via subcutaneous injection according to a dosing schedule determined by the child's age and weight. For children aged two to five years, the drug is given at 200 mg every four weeks for patients weighing at least 5 kg to less than 15 kg, and at 300 mg every four weeks for those weighing at least 15 kg to less than 30 kg, without an initial loading dose. In children and adolescents aged six to 17 years, the doses range between 200 mg and 300 mg, administered every two weeks or every four weeks depending on weight, after an initial loading dose. The medication should be administered by a caregiver in children aged two to 11 years when used at home. The safety outcomes from clinical studies have generally been consistent with the known safety profile of Dupixent in its approved dermatological indications.
