The Food and Drug Administration (FDA) in the United States has approved Dupixent (dupilumab) to treat chronic spontaneous urticaria in children aged two to eleven who remain symptomatic despite treatment with H1 antihistamines. This extension marks the first approval of a biologic drug in this pediatric indication in the United States.
Published on April 23, 2026 at 09:43.
Extension of Dupixent to young children with chronic urticaria:
Dupixent, developed jointly by Sanofi and Regeneron, expands its existing approval in adults and adolescents aged 12 and older with chronic spontaneous urticaria (CSU). This new indication pertains to children aged two to eleven who remain symptomatic despite treatment with H1 antihistamines. The drug inhibits the signaling of interleukins IL-4 and IL-13, two key factors in type 2 inflammation contributing to this disease. According to Sanofi, over 14,000 children aged two to eleven in the United States suffer from uncontrolled CSU with few alternative therapeutic options.
Clinical data and safety profile:
The approval is primarily based on the LIBERTY-CUPID study program, including two replicated phase 3 studies (A and C studies) conducted in patients aged six and older, and the single-arm phase 3 CUPIDKids study in children aged two to eleven. In studies A and C, Dupixent significantly reduced itching severity and hive activity compared to placebo at week 24 and increased the likelihood of disease control or complete response in adults and adolescents. The safety profile in children aged two to eleven was consistent with that observed in other approved dermatologic indications. The most common adverse reaction (< 2%) was a reaction at the injection site. No new adverse reactions were identified in children of this age group treated with Dupixent.
Sector: Pharmaceutical Industry and Biotechnology
Context: – Revenue: €43,626 million – Revenue Growth: 9.9% – Net Income: €9,555 million – Free Cash Flow: €8,089 million – Net Debt: €11,008 million – Dividend per share: €4.12
Guidance: – Expected revenue growth in 2026 at constant exchange rates. – Sanofi foresees solid and profitable growth in 2026 and plans a share buyback program of €1 billion in 2026; a dividend of €4.12 is proposed.
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[Context note: This article discusses the approval of Dupixent for pediatric use in the United States, highlighting its extension to children aged two to eleven with chronic spontaneous urticaria.]
[Fact Check note: The article provides financial data and guidance related to Sanofi’s performance and outlook in the pharmaceutical industry.]
