The European Commission approved Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of moderate‑to‑severe chronic spontaneous urticaria (CSU) in children aged two to eleven years, adding a new pediatric indication to the drug’s EU portfolio.
Dupixent’s approval is based on the LIBERTY‑CUPID clinical program, which included two phase‑3 studies in adults and adolescents and a single‑arm CUPIDKids study in children. The trials demonstrated significant reductions in urticaria activity, itch, and hive severity, with safety profiles consistent with Dupixent’s established record of tolerability.
The regulatory milestone expands Dupixent’s reach in the EU and is expected to contribute to continued sales growth. Global net sales of Dupixent reached about $18.5 billion last year, and the drug generated €15.7 billion in 2025, with Q4 2025 sales up 32.2% to €4.2 billion. The new pediatric indication opens a previously untapped market for a drug that already treats atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and bullous pemphigoid.
"Dupixent, which inhibits signalling of IL‑4 and IL‑13, two of the key drivers of type‑2 inflammation, provides a first‑of‑its‑kind approach to addressing chronic spontaneous urticaria in young children," said Dr. Alyssa Johnsen, Global Therapeutic Area Head, Immunology Development at Sanofi. "As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments," added Dr. George Yancopoulos, Board co‑Chair, President and Chief Scientific Officer at Regeneron.
The approval is significant because it marks Dupixent as the first targeted medicine approved in the EU for children aged 2‑11 with CSU, and it represents the fourth Dupixent approval for individuals younger than 12 years old with chronic diseases driven in part by type‑2 inflammation. The pediatric indication complements existing approvals and positions the drug to capture a market that has a high unmet medical need and limited therapeutic options.
Dupixent faces competition from biosimilar dupilumab candidates, but the new approval strengthens its market position and extends its lifecycle. The drug’s established safety profile and robust efficacy data give Sanofi and Regeneron confidence in the product’s ability to meet the needs of this new patient group.
The European Commission’s decision underscores the importance of targeted biologics in treating type‑2 inflammatory diseases and signals a continued focus on expanding Dupixent’s indications. The approval is expected to reinforce Sanofi’s and Regeneron’s leadership in immunology and to support the long‑term growth of a blockbuster product that has already become a cornerstone of their portfolios.
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