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 (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 (Study A, Study B, and Study C) for Dupixent in CSU. The sBLA adds results from Study C, which was conducted in patients with uncontrolled CSU who were on standard-of-care antihistamines. Study C, the second LIBERTY-CUPID pivotal study in biologic-naive patients, 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).
Addressing Unmet Needs in CSU Treatment
Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease driven in part by type-2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. More than 300,000 people in the US suffer from CSU that is inadequately controlled by antihistamines.
Dupixent's Mechanism and Prior Approvals
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of type-2 inflammation that play a major role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, CSU, and chronic obstructive pulmonary disease in different age populations. More than 1,000,000 patients are currently being treated with Dupixent globally.
LIBERTY-CUPID Phase 3 Program
The LIBERTY-CUPID Phase 3 study program evaluating Dupixent for CSU consists of Study A, Study B, and Study C. Study A and Study C were conducted in CSU patients who were uncontrolled on standard-of-care antihistamines while Study B was conducted in CSU patients who were uncontrolled on standard-of-care antihistamines and refractory or intolerant to omalizumab.
Safety results in all LIBERTY-CUPID phase 3 studies were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) compared to placebo were injection site reactions and COVID-19 infection.
