FDA Accepts Dupixent sBLA for Chronic Spontaneous Urticaria Treatment
Key Insights
The FDA has accepted the resubmitted sBLA for Dupixent to treat chronic spontaneous urticaria (search) (CSU) in patients 12 years and older whose condition is not adequately controlled by H1 antihistamines.
The sBLA is supported by data from the LIBERTY-CUPID phase 3 clinical program, which demonstrated significant reductions in itch and urticaria activity with Dupixent.
If approved, Dupixent would be the first targeted therapy for CSU in a decade, offering a new treatment option for over 300,000 Americans inadequately controlled by antihistamines.
The FDA has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (search) (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025.
The resubmitted sBLA is supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C met its primary and key secondary endpoints, confirming results seen in the previous Study A. Results showed Dupixent significantly reduced itch and urticaria activity (itch and hives).
Clinical Efficacy of Dupixent in CSU
The LIBERTY-CUPID Phase 3 study program evaluated Dupixent for CSU across three studies: Study A, Study B, and Study C. Studies A and C focused on patients uncontrolled on standard-of-care antihistamines, while Study B included patients uncontrolled on antihistamines and refractory or intolerant to omalizumab. The collective data from these studies underscore Dupixent's potential to address a significant unmet need in CSU management.
Safety Profile
Safety results across the LIBERTY-CUPID phase 3 studies were consistent with Dupixent's established safety profile. The most common adverse events (≥5%) observed with Dupixent compared to placebo were injection site reactions and COVID-19 infection.
Understanding Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria (search) (CSU) is a chronic inflammatory skin disease driven in part by type-2 inflammation, characterized by sudden hives and recurring itch. While H1 antihistamines are commonly used to manage symptoms, many patients remain uncontrolled, leading to a significant impact on their quality of life. It is estimated that more than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
Dupixent: A Targeted Approach
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways, key drivers of type-2 inflammation. It is not an immunosuppressant. Dupixent has already been approved for CSU in Japan and the United Arab Emirates (UAE) and is under regulatory review in the EU. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis (search), asthma (search), chronic rhinosinusitis with nasal polyps (search), eosinophilic esophagitis (search), prurigo nodularis (search), CSU, and chronic obstructive pulmonary disease (search) in different age populations. More than 1,000,000 patients are currently being treated with Dupixent globally.
Sanofi and Regeneron are jointly developing dupilumab under a global collaboration agreement. Dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type-2 inflammation.