The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on February 27 2026, recommending approval of Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in children aged two to eleven years.
The recommendation is based on the LIBERTY‑CUPID program, which included two phase‑3 studies (Study A and Study C) and a single‑arm CUPIDKids study. All studies enrolled children with moderate‑to‑severe CSU who had an inadequate response to standard antihistamine therapy and were naïve to anti‑IgE treatment. The data demonstrated clinically meaningful reductions in wheal‑pruritus scores and improved quality‑of‑life metrics, supporting the CHMP’s recommendation.
Dupixent has already achieved €4 billion in quarterly sales in adults and adolescents, with Q4 2025 global net sales of $4.9 billion, up 34 % versus Q4 2024, and full‑year 2025 sales of $17.8 billion, up 26 %. Sanofi’s Q4 2025 sales were €4.2 billion, up 32.2 % year‑over‑year, and first‑half 2025 sales were €7.3 billion, up 20.7 %. The global Dupixent market was valued at $15.5 billion in 2025 and is projected to exceed $30.3 billion by 2035, with the pediatric segment representing a significant growth opportunity.
The pediatric indication would be the first targeted therapy in the EU for children with CSU, giving Sanofi and Regeneron a competitive advantage over any potential entrants. Existing approvals for CSU in adults and adolescents, as well as indications for atopic dermatitis, asthma, and other type‑2 inflammatory diseases, position Dupixent as a versatile platform. The new label could broaden the drug’s reach and reinforce its leadership in the pediatric immunology market.
The final European Commission decision is expected in the coming months, while the U.S. Food and Drug Administration is anticipated to issue its decision by April 2026. The CHMP recommendation is a key regulatory milestone that could accelerate Dupixent’s launch in the EU and strengthen Sanofi’s and Regeneron’s market position.
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