Sanofi announced that the European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged two to 11 years with inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. This expands the previous approval in the EU for adults and adolescents aged 12 years and older with CSU, a chronic, inflammatory skin disease that causes sudden and debilitating hives and recurring itch. The approval in the EU is based on data from the LIBERTY-CUPID clinical study program. This includes an extrapolation of efficacy data in adults from two phase 3 studies (Study A and Study C; clinical study identifier: NCT04180488) complemented by pharmacokinetic, safety, and efficacy data from the single-arm CUPIDKids phase 3 study in children aged two to 11 years with CSU (clinical study identifier: NCT05526521). Study A and Study C demonstrated Dupixent significantly reduced urticaria activity (a composite of itch and hives) and individual measures of itch and hive severity compared with placebo at Week 24. Dupixent also increased the percentage of patients with well-controlled disease and complete response at Week 24 compared with placebo. Safety results from Study A, Study C, and CUPIDKids were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Additional adverse reactions of injection site induration, injection site dermatitis, and injection site bruising or hematoma were reported in the CSU adult and adolescent studies. The adverse event more commonly observed with Dupixent (5%) than placebo in Study A and Study in adults and adolescents with CSU was
COVID-19. Safety data for children aged two to 11 years with CSU were generally consistent with the safety profile for adult and adolescent patients with CSU treated with Dupixent.
Regeneron Pharmaceuticals, Inc. specializes in research, development, producing, and selling drugs used in treating ophthalmologic and inflammatory diseases and cancers. Net sales break down by type of revenue as follows:
- revenues from collaboration agreements (51.1%): collaboration with Sanofi (80.3% of revenues), Bayer (19.4%) and other (0.3%);
- revenues from product sales (30%);
- revenues from sales of technology licenses and subcontracted research services (4.9%).
At the end of 2025, the group had a portfolio of approximately 45 products in clinical development.
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