# Sanofi與Regeneron的Dupixent（dupilumab）獲准用於慢性自發性蕁麻疹兒童患者。

*biotech · news · 2026-05-06 · Medical Xpress*

## Key points

- FDA核准Dupixent用於2至11歲慢性自發性蕁麻疹兒童。
- Dupixent現為首個獲准用於年齡低至2歲慢性自發性蕁麻疹患者的生物製劑。
- 核准基於III期CUPIDKids研究中兒童的療效及藥物動力學數據。
- 臨床研究顯示Dupixent顯著降低搔癢嚴重度及蕁麻疹活動度，相較於安慰劑效果更佳。

The U.S. Food and Drug Administration has approved Sanofi and Regeneron's Dupixent (dupilumab) for the treatment of children (aged 2 to 11 years) with chronic spontaneous urticaria (CSU). This approval expands the previous approval for adults and adolescents ages 12 years and older with CSU who remain symptomatic despite histamine-1 antihistamine treatment. The fully human monoclonal antibody is administered as a subcutaneous injection. Data from the LIBERTY-CUPID clinical study program informed the approval, which included efficacy and safety data from two Phase III studies (study A and study C) in adults and adolescents aged 12 years and older with CSU, as well as pharmacokinetics data from the CUPIDKids Phase III study in children aged 2 to 11 years with CSU. Results from study A and study C showed that Dupixent significantly reduced itch severity and urticaria activity (a composite of itch and hives) versus placebo at week 24 and also increased the likelihood of well-controlled disease or complete response versus placebo. The safety of Dupixent was supported by data from pediatric patients in other indications. "Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease," Alyssa Johnsen, M.D., Ph.D., from Sanofi, the manufacturer of Dupixent, said in a statement. "Until now, these patients had to rely on limited treatment options that didn't address potential critical mediators of chronic spontaneous urticaria."

**Companies:** Sanofi, Regeneron
**Countries:** United States

[Read the full story on Medical Xpress](https://medicalxpress.com/news/2026-05-fda-dupixent-chronic-spontaneous-urticaria.html)

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