FDA Approves Dupilumab (Dupixent) for Chronic Spontaneous Urticaria in Patients Aged 12 and Older

On April 18, 2025, the US Food and Drug Administration (FDA) approved dupilumab (Dupixent) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite histamine-1 (H1) antihistamine therapy.¹

The FDA's approval was based on data from the LIBERTY-CUPID clinical trial program, which included 3 randomized, double-blind, placebo-controlled studies: CUPID-A, CUPID-B, and CUPID-C.

In CUPID-A and CUPID-C, biologic-naïve patients aged 12 years and older with CSU inadequately controlled by H1 antihistamines were randomized to receive dupilumab or placebo, both in addition to their existing antihistamine therapy. Patients receiving dupilumab demonstrated significant reductions in itch severity and urticaria activity scores compared to placebo at 24 weeks.

CUPID-B evaluated dupilumab in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use. While this study provided additional safety data, they did not meet the primary endpoint of reduction in itch severity score compared to placebo at 24 weeks.

Across the 3 studies, the safety profile of dupilumab was consistent with its known safety profile in other approved indications. The most common adverse event observed was injection site reactions. No new safety signals were identified.

For adults and adolescents aged 12 years and older with CSU, the recommended dosage of dupilumab is 300 mg administered subcutaneously every 2 weeks, following an initial loading dose. In adolescents weighing less than 60 kg, the recommended dosage is 200 mg every 2 weeks after an initial loading dose. Dupilumab can be administered in a clinical setting or at home after proper training by a health care professional.

Dupilumab's approval for CSU marks the first new targeted therapy for this condition in over a decade. The approval provides clinicians with a novel approach to managing CSU in patients aged 12 years and older who are inadequately controlled by H1 antihistamines. This is particularly significant given the limited treatment options available for this patient population.

Reference
1. Fitch J. FDA approves dupilumab for chronic spontaneous urticaria in ages 12 and up. Contemporary Pediatrics. Published April 18, 2025. Accessed April 22, 2025. https://www.contemporarypediatrics.com/view/fda-approves-dupilumab-for-chronic-spontaneous-urticaria-in-ages-12-and-up