FDA Approves Dupilumab for Chronic Spontaneous Urticaria Uncontrolled by Antihistamines

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The US FDA has approved dupilumab (Dupixent) as an add-on maintenance treatment for adults and adolescents aged ≥12 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with H₁ antihistamines. Dupilumab is the first targeted therapy approved for CSU in the US in more than a decade.

“People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives,” Kenneth Mendez, president and chief executive officer of the Asthma and Allergy Foundation of America, said in a Sanofi press release today. “The approval of this treatment offers patients more options and the chance to control their disease.”

The approval is based on the LIBERTY-CUPID phase 3 clinical trial program, which included three randomized, double-blind, placebo-controlled studies. Study A (n=136) and Study C (n=148) assessed dupilumab in biologic-naïve patients aged ≥12 years with CSU uncontrolled by antihistamines. Dupilumab significantly reduced itch severity at 24 weeks compared with placebo and also improved urticaria activity scores. Patients receiving dupilumab were more likely to achieve well-controlled disease (UAS7 ≤6) or complete response (UAS7=0) than those receiving placebo.

Study B (n=108) included patients aged ≥12 years who were symptomatic despite antihistamines and were inadequate responders or intolerant to anti–immunoglobulin E (IgE) therapy. This study did not meet the primary endpoint of itch severity reduction in the US but contributed additional safety data.

“CSU patients with uncontrolled disease experience highly burdensome itch and hives that can significantly disrupt daily living,” Alyssa Johnsen, MD, PhD, global therapeutic area head for immunology and oncology development at Sanofi, said in the press release. “This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms.”

In all 3 trials, dupilumab was administered every 2 weeks following a loading dose. Adolescent dosing varied by weight. Safety findings were consistent with the known profile of dupilumab, with injection site reactions being the most commonly reported adverse event (≥2%) occurring more frequently than with placebo.

“Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease,” George D. Yancopoulos, MD, PhD, board co-chair, president, and chief scientific officer at Regeneron, said in the release. “With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions."

Dupilumab is a monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling and is not classified as an immunosuppressant. It is approved in the US and internationally for multiple type 2 inflammatory diseases, including atopic dermatitis, asthma, and eosinophilic esophagitis.

More than 300 000 people in the US are estimated to have CSU that remains uncontrolled despite H₁ antihistamine treatment. Dupilumab is also approved for CSU treatment in Japan, the United Arab Emirates, and Brazil. Regulatory submissions are under review in other countries, including those in the European Union.

Reference: Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria. News release. Sanofi. April 18, 2025. Accessed April 18, 2025. https://www.news.sanofi.us/2025-04-18-Dupixent-approved-in-the-US-as-the-first-new-targeted-therapy-in-over-a-decade-for-chronic-spontaneous-urticaria