Sanofi and Regeneron have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Dupixent (dupilumab) for children aged two to 11 years with moderate-to-severe chronic spontaneous urticaria (CSU) who do not respond adequately to standard antihistamine treatment and have not received anti-immunoglobulin E therapy. The final decision from the European Commission is expected in the coming months.
If approved, Dupixent would become the first targeted medicine in the EU indicated for this age group with CSU that is inadequately controlled by antihistamines. CSU is a chronic skin condition characterized by hives and recurring itch, often significantly affecting quality of life in young children.
The CHMP’s recommendation is based on results from the LIBERTY-CUPID clinical program, which includes two phase 3 studies—Study A and Study C—involving children aged six to 11 years, as well as the CUPIDKids phase 3 study in children aged two to 11 years.
Dupixent already has approvals for treating CSU in certain adults and adolescents in several regions, including the US, EU, and Japan. In the United States, a supplemental biologics license application seeking approval for use in children aged two to 11 years with CSU is under review by the Food and Drug Administration, with a decision expected by April 2026.
The safety and efficacy of Dupixent for CSU in adults and adolescents are established only in jurisdictions where it has been approved. For children aged two to 11 years, these aspects have not yet been fully evaluated by any regulatory authority.
CSU is driven partly by type 2 inflammation. While antihistamines are commonly used as first-line therapy, many patients do not achieve adequate symptom control and may face limited treatment alternatives.
Dupixent is a monoclonal antibody designed to inhibit interleukin-4 (IL4) and interleukin-13 (IL13) pathways but does not act as an immunosuppressant. Clinical trials have shown that targeting these pathways can reduce type 2 inflammation associated with multiple diseases.
Currently, Dupixent holds regulatory approvals across more than 60 countries for various indications beyond CSU—including atopic dermatitis, asthma, eosinophilic esophagitis, prurigo nodularis, chronic rhinosinusitis with nasal polyps, bullous pemphigoid, allergic fungal rhinosinusitis, and chronic obstructive pulmonary disease—in different age groups. Over 1.4 million patients worldwide are being treated with Dupixent.
Sanofi and Regeneron continue research into additional uses of dupilumab through ongoing phase 3 studies addressing other inflammatory or allergic conditions such as chronic pruritus of unknown origin and lichen simplex chronicus. These uses remain under investigation pending further evaluation by regulatory authorities.
Regeneron describes itself as a biotechnology company focused on developing medicines for serious diseases using proprietary technologies like VelociSuite to create human antibodies. Sanofi positions itself as an R&D-driven biopharmaceutical company applying artificial intelligence to develop medicines aimed at improving lives globally.
Both companies caution that forward-looking statements about product development or potential approvals involve risks related to regulatory decisions or market acceptance.
