The European Commission approved Regeneron’s Dupixent (dupilumab) for the treatment of moderate‑to‑severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years, making it the first targeted medicine for this age group in the EU and expanding the drug’s pediatric portfolio.
The approval is based on the LIBERTY‑CUPID clinical trial program, which combined extrapolated efficacy data from adult Phase 3 studies with results from the single‑arm CUPIDKids Phase 3 study. The data demonstrated a significant reduction in urticaria activity, itch, and hives compared with placebo.
Regeneron had previously secured EU approval for Dupixent in adults and adolescents in November 2025, and the U.S. approval for the same indication was granted in April 2025. This EU approval marks the fourth Dupixent indication for individuals younger than 12 years across chronic diseases driven in part by type 2 inflammation.
"As the first and only targeted medicine for young children in the EU with CSU, Dupixent has the potential to become the new standard of care for those who remain symptomatic despite other available treatments," said Dr. George Yancopoulos. He added, "Dupixent is the most widely used innovative branded antibody medicine in the world, and this fourth approval for young children with chronic diseases driven in part by type 2 inflammation brings its proven efficacy and long‑term safety profile to yet another vulnerable population in need." "Dupixent, which inhibits signalling of IL4 and IL13, two of the key and central drivers of type 2 inflammation, provides a first‑of‑its‑kind approach to addressing chronic spontaneous urticaria in young children," said Dr. Alyssa Johnsen. She also noted, "Previous treatment options for young children with chronic spontaneous urticaria left many patients with uncontrolled disease where the unpredictable appearance of itch and hives continued to disrupt their daily lives."
Regeneron reported Q1 2025 revenues of $3.0 billion, with Dupixent global net sales increasing 19% to $3.67 billion versus Q1 2024. The company is scheduled to report its Q1 2026 financial results on April 29 2026, where the new pediatric indication is expected to add a new revenue stream and strengthen the overall portfolio.
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