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FDA Approves Dupilumab (Dupixent) for Chronic Spontaneous Urticaria
Dupilumab's approval marks the first new, targeted therapy for CSU in more than a decade and is the 7th indication for a disease with underlying type 2 inflammation.
The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) for the treatment of patients aged 12 years and older with chronic spontaneous urticaria (CSU) for whom CSU is uncontrolled with H1-antihistamines.1,3
The April 18, 2025, announcement by Regeneron indicates the approval is based on a pair of phase 3 LIBERTY-CSU CUPID Study A and Study C trials, which were 24-week, placebo-controlled, randomized trials assessing dupilumab in CSU. According to Regeneron, the approval marks the first new targeted therapy in more than a decade for CSU.
“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 cochair, president, and chief scientific officer at Regeneron, and a principal inventor of Dupixent, said in a statement.1 “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."
Despite the availability of H1 antihistamines as a treatment for CSU, medicines that target H1 receptors on cells to control symptoms of urticaria, those who continue to experience the disease’s symptoms remain uncontrolled. The FDA’s decision to approve dupilumab allows for an alternative therapeutic option for uncontrolled CSU.
Dupilumab is a fully human monoclonal antibody which is formulated to inhibit interleukin-4 (IL4) and interleukin-13 (IL13) signaling pathways. The drug is not an immunosuppressant, and has been given regulatory approvals in over 60 countries in 1 or more indications including atopic dermatitis, prurigo nodularis, and chronic obstructive pulmonary disease.
In the aforementioned pooled phase 3 LIBERTY-CSU CUPID Study A and Study C research, the findings of which had been presented at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego, involved an assessment of dupilumab in omalizumab-naïve individuals aged ≥ 6 years with symptomatic CSU.2
There were 138 subjects involved in study A and 151 in study C, and participants were randomized to be given add-on dupilumab, 300 mg for adults and 200 mg for children, or a placebo subcutaneously on an every-2-week basis. Adolescents were provided with either 300 mg or 200 mg of dupilumab. The results that occurred prior to the FDA approval indicated that dupilumab improved severity of itch and improved urticaria activity versus placebo at the 24-week mark.
There were greater proportions of individuals treated with dupilumab who achieved well-controlled disease status indicated by an Itch Severity Score of ≤ 6, with 43.1% versus 23.4% among those in the placebo arm (P < .0001).2 Additionally, 30.6% of those on dupilumab, compared to 15.9% on placebo, attained a complete response with an Itch Severity Score of 0 at the 24-week mark (P < .001).
The pooled analysis further demonstrated a comparable safety profile for dupilumab to its profile observed in prior research, with treatment-emergent adverse events taking place in 53.5% on dupilumab and 55.9% on placebo. Injection site reactions, accidental overdose, and COVID-19 infections were among the most common events highlighted in Study C.
“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 at the Asthma and Allergy Foundation of America, said in a statement.1 “The approval of this treatment offers patients more options and the chance to control their disease.”
References
Regeneron. Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU) | Regeneron Pharmaceuticals Inc. Regeneron Pharmaceuticals Inc. Published April 18, 2025. Accessed April 18, 2025. https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-new-targeted-therapy-over.
Casale T, Saini S, Bernstein J, et al. Dupilumab Improves Itch and Urticaria Activity In Patients With Chronic Spontaneous Urticaria: Pooled Results From Two Phase 3 Trials (LIBERTY-CSU CUPID Study A and Study C). Late-breaking abstract presented at AAAAI 2025 in San Diego from February 28 – March 3. Date accessed: April 17, 2025.
Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria. News release. Sanofi. November 15, 2024. Date accessed: April 17, 2025. https://www.sanofi.com/en/media-room/press-releases/2024/2024-11-15-06-00-00-2981756.
