FDA Accepts Application for Dupilumab to Treat Chronic Spontaneous Urticaria


The supplemental Biologics License Application was filed for the new indication for dupilumab, which is already approved to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.

The FDA is currently reviewing a supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) to treat chronic spontaneous urticaria (CSU), according to a statement from Regeneron and Sanofi.1 This inflammatory skin condition is marked by the sudden onset of debilitating hives and skin swelling—face, hands, and feet are the most common locations—and is known to have a significant adverse impact on patient quality of life.

Dupilumab is already approved to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis (EoE), and prurigo nodularis in more than 60 countries and has been used globally in more than 500,000 patients. This newest indication would be for the monoclonal antibody’s use in CSU among patients 12 years and older whose disease in inadequately controlled on H1 antihistamine treatment, the current standard of care.

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This sBLA was filed following the presentation of data from LIBERTY-CUPID Study A at this year’s American Academy of Allergy, Asthma and Immunology annual meeting, with subsequent publication in The Journal of Allergy and Clinical Immunology.2 The current CSU clinical trial program also includes LIBERTY-CUPID Study B. Both trials are phase 2 randomized double-blind placebo-controlled investigations looking at dupilumab use in patients with uncontrolled CSU.

Participants in Study A were 6 years and older (N = 138), and outcomes were compared between 2 groups: dupilumab plus standard-of-care H1 antihistamines vs antihistamines alone. All had a history of persistent symptomatic disease and were treatment-naïve to omalizumab. The patients in Study B (N = 108) were aged 12 to 80 years, with outcomes evaluated for dupilumab among those with an incomplete response to omalizumab or who were intolerant to that treatment.

Significant clinical benefits and decreased type 2 inflammation from inhibition of the IL-4 and IL-13 pathways have been seen throughout the medication’s development, “establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases,” noted the statement on the sBLA filing.

Phase 3 trials are also underway for dupilumab use in pediatric EoE, atopic hand and foot dermatitis, chronic inducible urticaria-cold, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, and bullous pemphigoid.

A decision from the FDA on this sBLA is expected October 22, 2023.


1. Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older accepted for FDA review. News release. Regeneron. March 7, 2023. Accessed March 7, 2023.

2. Dupilumab improves urticaria activity and quality of life in patients with chronic spontaneous urticaria (CSU). J Allergy Clin Immunol. 2023;151(2s). doi:10.1016/j.jaci.2022.12.315

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