FDA approves Dupixent (dupilumab) for children aged 2–11 years with chronic spontaneous urticaria, expanding treatment options for pediatric patients with uncontrolled disease.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
The US Food and Drug Administration has approved Dupixent® (dupilumab) for children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with second‑generation H1‑antihistamines, expanding its prior indication in patients aged 12 years and older.
CSU is a chronic inflammatory condition characterized by recurrent hives, often with angioedema and severe itching, that can markedly impair quality of life; many pediatric patients continue to experience uncontrolled symptoms despite standard therapy.
The approval is supported by the LIBERTY‑CUPID phase 3 program, including placebo‑controlled studies (Study A and Study C, NCT04180488) in patients aged 12 years and older, as well as pharmacokinetic and supportive efficacy and safety data from the CUPIDKids study (NCT05526521) in younger children.
In these trials, dupilumab significantly reduced itch severity and overall urticaria activity at 24 weeks compared with placebo and increased the likelihood of achieving well‑controlled disease or complete response in the older adolescent and adult populations.
Safety findings were consistent with the drug’s established profile, with injection‑site reactions being the most commonly reported adverse events and no new safety signals identified in children.
Dupilumab is a monoclonal antibody that inhibits interleukin‑4 and interleukin‑13 signaling, key drivers of type 2 inflammation underlying CSU and related conditions, and is administered as a subcutaneous injection with dosing based on age and weight.
Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology Development at Sanofi, noted that the approval provides a targeted treatment option for young patients with CSU whose disease remains uncontrolled despite existing therapies.
George D. Yancopoulos, MD, PhD, Board Co‑Chair, President and Chief Scientific Officer at Regeneron, highlighted that this represents the first biologic approval in the US for children 2–11 years with CSU and further reinforces the therapy’s established safety and broader role across type 2 inflammatory diseases.
Dupilumab is approved in more than 60 countries for multiple indications across age groups, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, chronic obstructive pulmonary disease, bullous pemphigoid, and allergic fungal rhinosinusitis, with over 1.4 million patients treated globally. It continues to be studied in additional conditions linked to type 2 inflammation.
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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.