FDA Reviewing Dupilumab for Chronic Spontaneous Urticaria

The US Food and Drug Administration (FDA) accepted review for the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) in the treatment of chronic spontaneous urticaria (CSU).¹ Regeneron Pharmaceuticals, Inc. and Sanofi submitted the review for the drug to treat CSU patients ages 12 and older. The current standard of care for CSU is an H1 antihistamine treatment. More than 300,000 (nearly 50%) CSU patients in the US report their condition is not adequately controlled by antihistamines.

The sBLA is supported by data from 2 phase 3 trials. The LIBERTY-CUPID Studies A (n=138) and B (n=108) were randomized, double-blind, placebo-controlled trials that evaluated the efficacy and safety of dupilumab in CSU treatment. Researchers examined how dupilumab targeted IL-4 and IL-13 proteins in patientswith uncontrolled CSU (ages 12-80) for 24 weeks. Results found the drug significantly reduced both the severity of itch and hives by 65% for patients, which was roughly double the effectiveness of the placebo test groups.

The FDA’s target date for a decision on the sBLA for dupilumab in CSU treatment is October 22, 2023.

CSU is the fifth condition dupilumab could be cleared to treat. Currently, the dupilumab is used as a prescription medicine to:

• Manage moderate-to-severe atopic dermatitis (AD) in adults and children older than 6 months who need more controlled treatment than topical therapies offer.
• Pair with other asthma medications for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children as young as 5-years old.
• Control chronic rhinosinusitis with nasal polyposis in adults.
• Treat adults and children 12 years and older weighing at least 88 pounds with eosinophilic esophagitis.
• Treat adults with prurigo nodularis.

In addition to CSU, Regeneron and Sanofi are also studying dupilumab’s safety and efficacy in chronic inducible urticaria triggered by cold in an ongoing phase 3 trial.

Reference

1. Dupixent® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older accepted for FDA Review. Regeneron Pharmaceuticals Inc. Published March 7, 2023. Accessed March 7, 2023. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-application-treatment-chronic-spontaneous.