Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announced on April 13, 2026, that the European Commission, has expanded the marketing authorization for Dupixent (dupilumab) to include children aged 2 to 11 years with moderate-to-severe chronic spontaneous urticaria (CSU).
The approval specifically targets patients who have shown an inadequate response to H1 antihistamines and have not yet received anti-IgE therapy.
Chronic spontaneous urticaria is characterized by the sudden onset of debilitating hives and persistent skin swelling (angioedema).
For pediatric patients, the condition can significantly disrupt sleep, school performance, and overall quality of life.
This approval makes Dupixent the first and only targeted biologic therapy in the European Union indicated for this specific pediatric population.
The Commission's decision was supported by data from the LIBERTY-CUPID clinical program.
This regulatory submission utilized an innovative approach, combining efficacy data from Phase 3 trials in adults and adolescents with safety and pharmacokinetic data from the CUPIDKids study, which focused specifically on the pediatric demographic.
The results demonstrated that Dupixent significantly reduced itch and hive activity compared to antihistamines alone.
With this latest authorization, Dupixent’s European label now covers four distinct diseases driven by type 2 inflammation in children under the age of 12.
The expansion further solidifies Dupixent’s position as a cornerstone of the Regeneron and Sanofi immunology franchise.
The drug continues to see rapid uptake globally, bolstered by its well-established safety profile and versatile application across multiple respiratory and dermatological conditions.