The FDA has extended the approval of dupilumab to children aged 2-11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with histamine 1 antihistamines (H1AH), according to a press release from the manufacturer Regeneron. 

The new indication follows the 2025 approval of dupilumab for adults and adolescents aged 12 years and older with CSU and the 2026 approval in the European Union for children aged 2-11 years with an inadequate response to H1AH and who are naive to anti-immunoglobulin E (anti-IgE) therapy for CSU.

Dupilumab, which is co-developed with Sanofi, is a fully human monoclonal antibody, works by inhibiting the signaling of the interleukin-4 (IL-4) and IL-13 pathways, according to the company.

The FDA approval was supported by data from the LIBERTY-CSU CUPID clinical trials program, with extrapolation of safety and efficacy data from the two phase 3 trials, LIBERTY-CSU CUPID Study A and Study C. In these studies, dupilumab significantly reduced itch severity and disease activity compared to placebo at 24 weeks after weight-based subcutaneous treatment every 2 weeks. Additional supporting data came from Study B, which included patients aged 12 years and older with inadequate response or intolerance to anti-IgE therapy and persistent symptoms despite antihistamine use. 

Pharmacokinetics data came from the single-arm, CUPIDKids phase 3 trial in children aged 2-11 years with CSU. Safety of the drug for that population was further supported by data from pediatric patients in other dupilumab indications, according to the company, and injection site reactions were the most common adverse event.

No new adverse reactions were identified in children aged 2-11 years with CSU treated with dupilumab, and the safety profile across all four LIBERTY studies for CSU is consistent with the drug’s other pediatric indications, which include atopic dermatitis and asthma. Dupilumab is also approved in the United States for chronic rhinosinusitis with nasal polyps in patients aged 12 years and older; allergic fungal rhinosinusitis in patients aged 6 years and older; eosinophilic esophagitis in adults and children 1 year of age and older who weigh at least 33 lbs; as well as chronic obstructive pulmonary disease, bullous pemphigoid, and prurigo nodularis in adults.