European Commission approves Dupixent (dupilumab) for children aged 2–11 years with chronic spontaneous urticaria, supported by LIBERTY-CSU CUPID trials, expanding biologic treatment options for pediatric patients with uncontrolled disease.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
The European Commission has approved Regeneron Pharmaceuticals and Sanofi’s Dupixent for children aged 2 to 11 years with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamines and are naïve to anti-IgE therapy. The decision expands the therapy’s European indication beyond adults and adolescents, bringing a targeted biologic option to younger pediatric patients with uncontrolled disease.
CSU is a chronic inflammatory skin condition characterized by recurrent hives and severe itch that can significantly affect quality of life. Many pediatric patients remain symptomatic despite antihistamines, leaving limited treatment alternatives. The approval introduces a targeted therapy designed to address underlying type 2 inflammation rather than only controlling symptoms.
Phase 3 Program Supported Pediatric Expansion
The authorization is based on data from the LIBERTY-CUPID clinical program (NCT04180488), including extrapolated efficacy from two Phase 3 trials (Study A and Study C) in older populations and supportive pharmacokinetic, efficacy, and safety data from the CUPIDKids Phase 3 trial (NCT05526521) in children aged 2–11 years.
In Study A and Study C, dupilumab significantly reduced overall urticaria activity, itch severity, and hive severity versus placebo at week 24. The trials also showed higher rates of well-controlled disease and complete response compared with standard therapy alone.
Safety findings across Study A, Study C, and CUPIDKids were consistent with the established profile of dupilumab. Common adverse reactions included injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia. Pediatric safety outcomes were broadly aligned with those observed in adults and adolescents.
Mechanism Targets Type 2 Inflammation
Dupilumab is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling, two central drivers of type 2 inflammation. By blocking these pathways, the therapy aims to reduce the underlying inflammatory processes contributing to CSU rather than only alleviating symptoms.
Company Perspective
George D. Yancopoulos, MD, PhD, Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent said the approval brings the first targeted treatment option for young children with CSU in the EU and could establish a new standard of care for those remaining symptomatic despite existing therapies.
Alyssa Johnsen M.D., Ph.D., Global Therapeutic Area Head, Immunology Development at Sanofi emphasized that dupilumab’s IL-4 and IL-13 inhibition offers a novel approach for pediatric CSU and addresses unmet need in children with uncontrolled disease.
Regulatory Status and Development
In addition to CSU, Dupixent has received approvals in more than 60 countries across multiple type 2 inflammatory diseases, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, bullous pemphigoid and allergic fungal rhinosinusitis across different age groups. More than 1.4 million patients are currently treated with dupilumab globally, reflecting its broad clinical use across dermatologic, respiratory and allergic conditions.
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About the Writer
Vennela Reddy, BPharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.