The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for dupilumab for the treatment of patients 12 years of age and older with chronic spontaneous urticaria (CSU) that is inadequately controlled with standard-of-care (SOC), H1 antihistamines.
The sBLA is supported by data from Studies A and B of the randomized, double-blind, placebo-controlled phase 3 LIBERTY-CUPID trial (ClinicalTrials.gov Identifier: NCT04180488), which evaluated the efficacy and safety of dupilumab in patients with CSU. Study A included patients who were inadequately controlled on SOC antihistamines; and Study B included patients who were inadequately controlled on SOC antihistamines and refractory to omalizumab.
In Study A, treatment with dupilumab plus SOC antihistamines met the primary endpoint achieving a 63% reduction in itch severity in biologic-naive patients at week 24 compared with a 35% reduction with antihistamines alone (10.24 point reduction vs 6.01 point reduction, respectively; P <.001). Moreover, the addition of dupilumab met all key secondary endpoints.
Findings from Study B showed that treatment with dupilumab achieved positive numerical trends in reducing itch and hives; however, it failed to meet statistical significance during an interim analysis conducted by an independent review committee. The Company decided to discontinue Study B in February 2022 due to futility.
The FDA has set a target action date of October 22, 2023 for the application.
Dupilumab is currently marketed under the brand name Dupixent® and is approved for the treatment of moderate to severe atopic dermatitis in patients 6 months of age and older; for maintenance treatment of severe asthma in patients 6 years of age and older; chronic rhinosinusitis with nasal polyps in patients 18 years of age and older; eosinophilic esophagitis in patients 12 years of age and older; and for prurigo nodularis in patients 18 years and older.
- 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 Pharmaceuticals, Inc. Accessed March 7, 2023. https://www.globenewswire.com/news-release/2023/03/07/2621674/0/en/Dupixent-dupilumab-Application-for-Treatment-of-Chronic-Spontaneous-Urticaria-CSU-in-Adults-and-Adolescents-Aged-12-Years-and-Older-Accepted-for-FDA-Review.html.
- Dupixent® (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients. News release. Regeneron Pharmaceuticals, Inc. July 29, 2021. Accessed March 7, 2023. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-significantly-improved-itch-and-hives/.