FDA Accepts sBLA for Dupilumab as Treatment for Those With Chronic Spontaneous Urticaria


More than 300,000 individuals in the United States have CSU that is inadequately controlled by antihistamines.

RFBSIP / stock.adobe.com

RFBSIP / stock.adobe.com

The FDA has accepted Sanofi’s supplemental biologics license application for review (sBLA) for dupilumab (Dupixent) for the treatment of individuals aged 12 years and older with chronic spontaneous urticaria (CSU) that is not adequately controlled with the standard of care, H1 antihistamine treatment.1

Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways. It is not an immunosuppressant. The target action date for the decision is October 22, 2023.1

The sBLA is supported by data from 2 phase 3 trials, LIBERTY-CUPID Studies A and B (NCT04180488), which evaluated dupilumab in individuals with uncontrolled CSU. The 2 studies were double-blinded, placebo-controlled, randomized trials that evaluated the efficacy and safety of the drug in 2 different patient populations with uncontrolled CSU.1

In Study A, investigators evaluated efficacy and safety data from individuals who had uncontrolled CSU and were on standard-of-care antihistamine, which supported the submission. Dupilumab was used as an add-on therapy to the standard-of-care H1 antihistamine compared with antihistamines alone in 138 individuals. Individuals were aged 6 years and older who remained symptomatic, despite being on antihistamines and were not previously treated with omalizumab.1

Topline results were announced in July 2021 at the American Academy of Allergy, Asthma, and Immunology Annual Meeting, demonstrating that dupilumab added to the standard of care and nearly doubled the reduction in itch and urticaria activity.2

In Study B, investigators evaluated additional supporting data from individuals with CSU who were uncontrolled on standard-of-care antihistamines and refractory to omalizumab. Dupilumab was evaluated in 108 individuals with CSU aged 12 to 80 years who remained symptomatic despite standard-of-care treatment and were incomplete or intolerant responders to omalizumab.1

The potential use of dupilumab in CSU is under clinical development, and the efficacy and safety data have not been fully evaluated by any regulatory authorities.

In addition to CSU, Regeneron and Sanofi are also studying dupilumab in chronic inducible urticaria triggered by a cold in an ongoing phase 3 trail, LIBERTY-CINDU CUrIADS (NCT04681729).1

CSU is an inflammatory skin condition that can be triggered by type 2 inflammation, which can cause debilitating and sudden and hives and swelling on the skin. Typically, it is treated with H1 antihistamines, which target the histamine-1 receptors on cells to control the symptoms.1

However, the disease remains uncontrolled in some patients, who do not have many alternative treatment options, according to investigators.1

Dupilumab is approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. It is approved for 1 or more of these indications in more than 60 countries, including Europe, Japan, and the United States.1


1. Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review. Sanofi. News release. March 7, 2023. Accessed March 7, 2023. https://www.news.sanofi.us/2023-03-07-Dupixent-R-dupilumab-application-for-treatment-of-chronic-spontaneous-urticaria-CSU-in-adults-and-adolescents-accepted-for-FDA-review

2. Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria. Sanofi. News release. February 26, 2022. Accessed March 7, 2023. https://www.sanofi.com/en/media-room/press-releases/2022/2022-02-26-17-00-00-2392625

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