The U.S. Food and Drug Administration (FDA) is reviewing Sanofi and Regeneron's supplemental Biologics License Application (sBLA) to expand the use of Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) in patients aged 12 years and older whose condition is not adequately controlled by H1 antihistamine therapy. The FDA's target decision date is April 18, 2025.
Dupixent's Mechanism and Clinical Data
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways, distinguishing it from other immunosuppressants used for CSU. The sBLA includes pivotal results from Study C of the LIBERTY-CUPID Phase III clinical trial (NCT04180488), which focused on biologic-naive patients with uncontrolled CSU receiving standard-of-care antihistamines.
Study C met its primary and key secondary endpoints, demonstrating that Dupixent significantly reduced itch and urticaria activity. These results align with earlier findings from Study A within the LIBERTY-CUPID program. Safety data across the program were consistent with Dupixent’s established safety profile, with common adverse events including injection site reactions and COVID-19 infections.
Global Approvals and Market Expansion
Dupixent has already been approved for CSU in Japan and the United Arab Emirates (UAE), and is currently under regulatory review in the European Union. Outside of these regions, the safety and efficacy of Dupixent in CSU are still under evaluation. In September 2024, the FDA approved Dupixent for chronic obstructive pulmonary disease (COPD), marking its sixth indication.
The Burden of Chronic Spontaneous Urticaria
CSU is a skin condition characterized by persistent, itchy hives that last for six weeks or longer. While antihistamines and anti-inflammatory treatments are commonly used to manage symptoms, a significant unmet need remains for more effective options in patients with uncontrolled disease.
Competitive Landscape
Novartis is also advancing its CSU pipeline with ligelizumab. Phase III study results released in May 2024 showed that nearly half of patients were completely free of itch and hives at week 52, as assessed by urticaria activity scores. Novartis plans to submit ligelizumab for regulatory approval in the second half of 2024.
Financial Projections
Dupixent generated $11.3 billion (€10.7 billion) in global sales in 2023, according to Regeneron’s financials. GlobalData’s Pharma Intelligence Center projects that Dupixent's revenue could reach $23.6 billion by 2030.
