FDA Sets April 2025 Target Date for Dupixent sBLA in Chronic Spontaneous Urticaria
核心洞察
The FDA has accepted the resubmission of the sBLA for Dupixent (dupilumab) for treating adults and children aged 12 and older with chronic spontaneous urticaria (搜索) (CSU).
The target action date for the FDA decision regarding Dupixent's application for CSU is set for April 18, 2025.
The resubmitted sBLA is supported by data from the Phase 3 LIBERTY-CUPID clinical program, demonstrating Dupixent's efficacy in reducing itch and hives in CSU patients.
The FDA has set a target action date of April 18, 2025, for the resubmitted supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in treating adults and pediatric patients (12 years and older) with chronic spontaneous urticaria (搜索) (CSU). This decision follows the FDA's initial complete response letter in October 2023, which requested additional efficacy data to support the approval. Dupixent, developed by Regeneron and Sanofi, is already approved for conditions like atopic dermatitis (搜索), asthma (搜索), prurigo nodularis (搜索), eosinophilic esophagitis (搜索) and chronic obstructive pulmonary disease (搜索) (COPD (搜索)).
Clinical Data Supporting Resubmission
The resubmitted sBLA is backed by data from the multi-study LIBERTY-CUPID phase 3 clinical program, including results from Study C. This study involved patients with uncontrolled CSU despite standard-of-care antihistamine treatment. Study C met its primary and key secondary endpoints, demonstrating a significant reduction in both itch and urticaria activity (itch and hives) with Dupixent.
In Study C, 151 adults and children were enrolled, with 74 receiving Dupixent in addition to antihistamines and 77 receiving placebo plus antihistamines. At 24 weeks, 41% of patients treated with Dupixent achieved well-controlled disease status, and 30% experienced a complete response.
Chronic Spontaneous Urticaria and Dupixent Mechanism
Chronic spontaneous urticaria (搜索) is a chronic inflammatory skin disease characterized by sudden and debilitating hives and recurring itch, affecting over 300,000 people in the United States whose symptoms are inadequately controlled by antihistamines. The condition is driven by type 2 inflammation.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (搜索) (IL-4 (搜索)) and interleukin-13 (搜索) (IL-13 (搜索)) pathways, key drivers of type 2 inflammation.
Expert Commentary
According to Thomas B. Casale, M.D., professor at the University of South Florida, "Chronic spontaneous urticaria (搜索) is an inflammatory skin condition that affects patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives. These data confirm results seen in the previous Study A and reinforce the potential of Dupixent to significantly alleviate symptoms for patients, helping them to better control this challenging disease."
Safety Profile
The safety results from the LIBERTY-CUPID phase 3 studies were consistent with the established safety profile of Dupixent across its approved indications. The most common adverse events observed with Dupixent compared to placebo were injection site reactions and COVID-19 infection.