On April 18, 2025 the U.S. Food and Drug Administration granted approval to dupilumab (brand name Dupixent) for treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older who remain symptomatic despite treatment with H1 antihistamines. This marks the first new targeted therapy for CSU in over ten years.

CSU is a condition in which patients suffer recurring hives and often severe itch, for no identifiable external trigger, lasting more than six weeks. The disease can severely disrupt quality of life. Many patients rely on standard first line therapies such as antihistamines, but a substantial number do not get adequate relief. Until now treatment options for those patients have been limited.

The approval is based mainly on data from the LIBERTY-CUPID phase 3 studies, particularly Studies A and C. These were randomized, placebo-controlled, double-blind trials in patients who were still symptomatic despite antihistamines. The trials compared dupilumab added on top of antihistamines versus placebo plus antihistamines over a 24-week period.

Key findings included:

• Significant reductions in itch severity at 24 weeks among patients treated with dupilumab compared to placebo.
• Meaningful improvement in the urticaria activity score, which combines measurements of hives and itch.
• Higher proportions of patients reaching well-controlled disease or even complete response compared to placebo.

Safety results were in line with what has been observed in other approved uses of dupilumab. The most common side effects were mild to moderate injection site reactions, and no new safety concerns emerged.

For dosing in adults and adolescents aged 12 and older, the regimen involves a loading dose followed by dupilumab 300 mg every two weeks. For adolescents below a certain weight, the recommended maintenance dose is 200 mg every two weeks. Treatment may be administered in clinic or at home under medical supervision.

This approval is significant because it gives clinicians and patients another therapeutic option when antihistamines alone are not enough. It also expands the role of dupilumab into another condition driven by type 2 inflammation. The drug is already approved for atopic dermatitis, asthma, and nasal polyposis, and CSU now joins that list.

From a clinical research standpoint, the LIBERTY-CUPID trials strengthen evidence for targeting IL-4 and IL-13 pathways in chronic inflammatory conditions beyond those originally studied. The durability of response over 24 weeks is particularly encouraging given the long-term nature of CSU.

For patients, the benefits go beyond reduction in hives and itch. Effective control of CSU can improve sleep, reduce anxiety, and restore daily functioning. With this regulatory decision, people living with chronic spontaneous urticaria finally have a new treatment option after more than a decade of limited progress.