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news.The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union (EU) for paediatric patients with chronic spontaneous urticaria (CSU).
CSU is a chronic skin disease driven partly by type 2 inflammation, leading to severe itching and hives. Credit: Pormezz / Shutterstock.com.
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The recommendation applies to children aged two to 11 years experiencing moderate-to-severe CSU who do not respond adequately to histamine-1 antihistamines and are naïve to anti-immunoglobulin E (IgE) therapy.
It is based on results from the LIBERTY-CUPID clinical programme, including two Phase III trials (Study A and Study C) involving children aged six to 11 years, and the single-arm CUPIDKids Phase III study for children aged two to 11 years with CSU.
A final decision is anticipated in the coming months.
Dupixent is already approved for use in certain adults and adolescents with CSU in regions including the EU, Japan, and the US.
In the US, a supplemental biologics licence application is under review to extend approval of Dupixent for children aged two to 11 years, with a decision from the US Food and Drug Administration (FDA) anticipated by April 2026.
CSU is a chronic skin disease driven partly by type 2 inflammation, leading to severe itching and hives.
Dupixent is a human monoclonal antibody targeting interleukin-4 and interleukin-13 pathways without serving as an immunosuppressant. It is being jointly developed by Sanofi and Regeneron and studied across over 60 clinical trials involving more than 12,000 patients with type 2 inflammation-driven diseases.
Ongoing Phase III studies are evaluating further potential indications.
In December 2025, China’s National Medical Products Administration (NMPA) granted approval for Sanofi’s rare haematologic disease treatments, Qfitlia (fitusiran) and Cablivi (caplacizumab), for patients with haemophilia and acquired thrombotic thrombocytopenic purpura (aTTP), respectively.
