Brussels approves Sanofi's Dupixent for CSU in children
Sanofi has announced that the European Commission has approved Dupixent (dupilumab) as the first targeted treatment for chronic spontaneous urticaria (CSU), a chronic inflammatory skin condition, in young children.
Specifically, this clearance covers moderate-to-severe forms of the disease in children aged 2 to 11 who show an inadequate response to H1 antihistamines and have not previously received anti-immunoglobulin E (IgE) therapy for CSU.
The Commission's decision is based on data from the LIBERTY-CUPID clinical trial program, including an extrapolation of efficacy data showing that Dupixent significantly reduced urticaria activity compared to placebo in adults.
This latest approval expands Dupixent's CSU indication in the EU to children as young as 2; Dupixent is now approved for children under 12 for four chronic diseases partially driven by type 2 inflammation.
The French healthcare giant also noted that in the United States, the supplemental Biologics License Application for Dupixent has been accepted for review for certain children aged 2 to 11 with CSU.
Sanofi is the largest European pharmaceutical group. Net sales by family of products break down as follows:
- pharmaceutical products (81.8%): prescription drugs for the treatment of multiple sclerosis, neurological diseases, inflammatory diseases, autoimmune diseases, rare diseases, cancers and rare hematological diseases;
- human vaccines (18.2%): pediatric vaccines, vaccines for flu, meningitis, and polio, booster vaccines, and vaccines for travelers and endemic areas.
At the end of 2025, the group had 37 production sites worldwide.
Net sales are distributed geographically as follows: France (3.9%), Europe (17.1%), the United States (50.8%), China (6%) and other (22.2%).
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