The FDA has accepted for review Sanofi and Regeneron's resubmitted supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older whose disease is inadequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025. If approved, Dupixent would be the first targeted therapy for CSU in a decade.
The resubmitted sBLA is backed by data from the multi-study LIBERTY-CUPID phase 3 clinical program, which includes Study A, Study B, and Study C. Study C, the second pivotal study in biologic-naïve patients, met its primary and key secondary endpoints, confirming results seen in the previous Study A. The studies showed Dupixent significantly reduced itch and urticaria activity (itch and hives).
LIBERTY-CUPID Phase 3 Trial Results
The LIBERTY-CUPID Phase 3 study program evaluated Dupixent in CSU patients uncontrolled on standard-of-care antihistamines (Study A and Study C) and in those refractory or intolerant to omalizumab (Study B). Safety results across the LIBERTY-CUPID phase 3 studies were consistent with Dupixent's known safety profile. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo were injection site reactions and COVID-19 infection.
Unmet Needs in CSU Treatment
CSU is a chronic inflammatory skin disease driven in part by type-2 inflammation, causing sudden hives and recurring itch. It affects more than 300,000 people in the US whose symptoms are inadequately controlled by antihistamines. These patients often have limited treatment options and experience debilitating symptoms that significantly impact their quality of life.
Dupixent's Mechanism of Action
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development program has demonstrated significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL-4 and IL-13 are key drivers of type-2 inflammation in multiple related diseases.
Dupixent has already received regulatory approvals in more than 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease. More than 1,000,000 patients are currently being treated with Dupixent globally.
Sanofi and Regeneron are also studying dupilumab in a broad range of diseases driven in part by type-2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and bullous pemphigoid. The safety and efficacy of dupilumab in these conditions have not been fully evaluated by any regulatory authority.
