The European Commission has approved Dupixent (dupilumab) for moderate-to-severe chronic spontaneous urticaria in children aged two to 11 years, making it the first targeted medicine authorised for this pediatric age group in the EU. Sanofi and Regeneron Pharmaceuticals, which jointly develop dupilumab, said the decision extends an existing EU approval covering adults and adolescents aged 12 and older. The approval also marks the fourth indication in which Dupixent is now authorised for children under 12 years in the EU across chronic diseases driven in part by type 2 inflammation.
The approval covers children who remain symptomatic despite histamine-1 antihistamine treatment and who are naïve to anti-immunoglobulin E therapy for CSU. Dosing is weight- and age-based: children aged two to five years receive 200 mg every four weeks if weighing 5 kg to under 15 kg, or 300 mg every four weeks if weighing 15 kg to under 30 kg, without an initial loading dose. In the US, a supplemental biologics license application for dupilumab in children aged two to 11 years with CSU has been accepted for review, the companies said.
The EU decision draws on data from the LIBERTY-CUPID Phase III clinical study program. This included an extrapolation of efficacy data from two Phase III adult studies, Study A and Study C, which were replicate double-blind, placebo-controlled trials assessing dupilumab as add-on therapy to antihistamines in patients aged six and older naïve to anti-IgE therapy. Both studies measured change from baseline in the weekly urticaria activity score at Week 24 as the primary endpoint, a composite of itch and hive severity on a 0–42 scale. Dupilumab significantly reduced urticaria activity and increased the proportion of patients with well-controlled disease and complete response compared with placebo. Pharmacokinetic, safety, and efficacy data from CUPIDKids (NCT05526521), a single-arm Phase III study in children aged two to 11 years, complemented the adult extrapolation. The primary endpoint in CUPIDKids was serum dupilumab concentration over time. Safety findings across all three studies were consistent with dupilumab’s established profile in dermatological indications; the most common adverse reactions included injection site reactions, conjunctivitis, and eosinophilia.
CSU is a chronic inflammatory skin condition in which mast cell activation drives unpredictable episodes of hives and itch. Standard first-line treatment relies on H1 antihistamines, but a substantial proportion of patients remain symptomatic despite antihistamine use, leaving limited alternatives — particularly in young children, where therapeutic options have historically been constrained. Dupilumab inhibits signalling of interleukin-4 and interleukin-13, two cytokines central to type 2 inflammation, and is not classified as an immunosuppressant.
The CSU pipeline for adults has grown considerably more crowded. Celldex Therapeutics is advancing barzolvolimab, an anti-KIT monoclonal antibody that depletes mast cells, through Phase III HARBOR trials. Novartis is running Phase III studies with remibrutinib, an oral BTK inhibitor, in the REMIX-1 and REMIX-2 trials. Sanofi itself is also developing rilzabrutinib, a BTK inhibitor, in Phase II/III for CSU, alongside its approved dupilumab programme. The pediatric segment, however, currently has no other approved targeted therapy, leaving dupilumab without direct competition in this age group for now.