FDA
FDA expands Dupixent approval to young children with chronic spontaneous urticaria
On April 22, 2026, FDA approved Dupixent (dupilumab) for children ages 2 to 11 years with chronic spontaneous urticaria (CSU) that remains symptomatic despite H1 antihistamine therapy. The decision marks the first biologic approved in the U.S. for this population and expands prior approval for adolescents and adults, addressing a long‑standing therapeutic gap in pediatrics.
CSU is an inflammatory skin disease driven in part by type 2 inflammation, resulting in recurrent hives and persistent itch. While symptoms are typically treated with H1 antihistamines, disease remains uncontrolled in more than 14,000 U.S. children ages 2 to 11, many of whom have had limited alternative options. Ongoing symptoms can be debilitating and significantly affect quality of life.
Dupixent targets IL‑4 and IL‑13 signaling, central drivers of type 2 inflammation, offering a disease‑directed approach rather than symptom suppression.
Approval was based primarily on the LIBERTY‑CUPID phase 3 program. Two replicate, double‑blind, placebo‑controlled studies (Study A and Study C) evaluated dupilumab as add‑on therapy to standard antihistamines and demonstrated significant reductions in itch severity and overall urticaria activity compared with placebo at week 24, using validated scales (weekly itch severity score [0–21] and UAS7 [0–42]). Pediatric approval was supported by efficacy and safety extrapolation from these trials, along with pharmacokinetic and safety data from the single‑arm CUPIDKids study in children ages 2 to 11 years.
Across studies, safety was consistent with the known dupilumab profile, with injection‑site reactions reported as the most common adverse event and no new pediatric safety signals identified.
“With this approval, Dupixent has become the first biologic medicine in the U.S. for young children suffering from uncontrolled chronic spontaneous urticaria, an unpredictable skin disease that impacts quality of life during these children’s most formative years,” said George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron.
Source: Sanofi. (2026, April 22). Press release. Sanofi and Regeneron’s Dupixent approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria