Dupixent approved in the U.S. for young children with uncontrolled chronic spontaneous urticaria
Thursday, April 23, 2026
Regeneron Pharmaceuticals and Sanofi have received approval from the U.S. Food and Drug Administration for Dupixent (dupilumab) to treat children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who continue to show symptoms despite treatment with H1 antihistamines. The decision expands the medicine’s earlier approval, which covered adults and adolescents aged 12 years and above.
Dupixent becomes the first biologic medicine in the United States approved for young children with uncontrolled CSU, a condition marked by recurring itch and hives that can affect daily life.
The approval is mainly supported by data from the LIBERTY-CUPID clinical programme. Evidence includes results from Phase 3 studies in adults and adolescents, along with pharmacokinetic data from a paediatric trial involving children aged 2 to 11 years. Across the studies, Dupixent reduced itch severity and overall disease activity compared to placebo at 24 weeks. It also improved the chances of achieving well-controlled disease or complete response in older patients.
Additional trial data supported its use in patients who did not respond well to or could not tolerate anti-IgE therapy. Safety findings in children were further supported by data from other approved uses of the medicine.
The overall safety profile was consistent with previous findings in dermatology indications. The most commonly reported side effect was injection site reactions, with no new safety concerns identified in the paediatric group.
Dupixent works by blocking IL-4 and IL-13 signalling, which are key drivers of type 2 inflammation linked to CSU. The approval provides a targeted treatment option for young patients with limited alternatives.
Beyond the United States, Dupixent is also approved for CSU in certain children aged 2 to 11 years in Europe and other regions.
Source: globenewswire.com
