April 23, 2026
2 min read
Key takeaways:
- Approval of dupilumab was extended to include children aged 2 to 11 years with chronic spontaneous urticaria.
- The approval was supported by data from the LIBERTY-CUPID clinical trial program.
The FDA approved dupilumab to treat children aged 2 to 11 years with chronic spontaneous urticaria and persistent symptoms despite H1 antihistamine treatment, according to a company press release.
The FDA’s decision expands the April 2025 approval of dupilumab (Dupixent, Regeneron/Sanofi) for chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older.
The FDA approved dupilumab for children aged 2 to 11 years with persistent chronic spontaneous urticaria symptoms despite H1 antihistamine treatment.
“Before this approval, only antihistamines were approved for children younger than 12 years of age. Since about 50% of patients do not adequately respond to antihistamines alone, this leads to a gap in the treatment of [these] children,” Thomas B. Casale, MD, professor of medicine and pediatrics at University of South Florida in Tampa and an investigator for the LIBERTY-CUPID clinical trial program, told Healio. “Because CSU is associated with decreased quality of life, anxiety and more, providing a therapeutic option for children with antihistamine unresponsiveness is a much-needed addition to our therapeutic armamentarium.”
As Healio previously reported, CSU affects approximately 1.7 million people in the United States and is characterized by red, swollen and itchy hives that are unpredictable, recur for 6 weeks or more and do not have an identifiable cause.
Alyssa Johnsen
“Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits [interleukin]-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease,” Alyssa Johnsen, MD, PhD, global therapeutic area head of immunology development at Sanofi, said in the release.
The new approval was primarily supported by data from the LIBERTY-CUPID clinical study program, including two phase 3 studies, Study A and Study C, that included adults and adolescents aged 12 years and older with CSU, as well as pharmacokinetics data from the phase 3 CUPIDKids study that included children aged 2 to 11 years with CSU.
For 24 weeks, participants in Study A and Study C were assigned dupilumab 200 mg every 2 or 4 weeks or 300 mg every 4 weeks based on weight and age. At the end of Study A, dupilumab had reduced itch severity by 63% and urticaria activity by 65% (P < .001). In contrast, placebo reduced itch by 35% and urticaria activity by 37%, according to the release.
Additional findings from Study C showed a higher proportion of participants assigned dupilumab compared with placebo achieved well-controlled disease status (41% vs. 23%; P = .005) and complete response (30% vs. 18%; P = .02), according to the release.
In addition, Study B in the LIBERTY-CUPID program showed dupilumab’s safety profile was consistent with its known safety profile in its approved dermatologic indications. The most common adverse event was injection site reactions, occurring in 2% or more participants. Investigators did not observe any new safety events in children aged 2 to 11 years, according to the release.
“Dupixent is now approved for nine different allergy-related conditions, from asthma to atopic dermatitis, and this is the fifth of these indications now extended to young children,” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, said in the release.
For more information:
Thomas B. Casale, MD, can be reached at tbcasale@usf.edu.
Sources/Disclosures
Source:
Press Release
References:
Disclosures:
Casale reports being an investigator for the LIBERTY-CUPID clinical trial program and a member of ARS Pharma’s scientific advisory board. Johnsen is an employee of Sanofi. Yancopoulos is an employee of Regeneron.
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