for chronic spontaneous urticaria in children
FDA approved Dupixent (dupilumab) for children aged two to 11 years with chronic spontaneous urticaria who remain symptomatic despite antihistamine treatment.
Chronic spontaneous urticaria is a skin condition causing unpredictable, itchy hives and swelling that can last for months or years. Dupilumab is an injected antibody that blocks two key immune proteins (IL-4 and IL-13) that drive inflammation. By quieting this specific immune pathway, the drug may reduce the frequency and severity of hives in children whose symptoms continue despite standard antihistamines.
This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment
Source: ClinicalTrials.gov