FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic spontaneous urticaria (CSU).
The application seeks to expand Dupixent’s use to treat adults and adolescents (aged 12 and older) with CSU inadequately controlled by H1 antihistamine therapy. The FDA’s target decision date is 18 April 2025.
Dupixent, a fully human monoclonal antibody, inhibits the signalling of IL-4 and IL-13 pathways and is different from other immunosuppressants used to treat this condition. The resubmission builds on data from the LIBERTY-CUPID Phase III clinical trial (NCT04180488), which included three studies (Study A, Study B, and Study C). The sBLA adds pivotal results from Study C, conducted in biologic-naive patients with uncontrolled CSU who were receiving standard-of-care antihistamines.
Study C met both its primary and key secondary endpoints, demonstrating that Dupixent significantly reduced itch and urticaria activity (hives and itch severity), aligning with earlier results from Study A. Safety data across the LIBERTY-CUPID programme were consistent with Dupixent’s established safety profile, with common adverse events including injection site reactions and Covid-19 infections.
Dupixent has already been approved for CSU in Japan and the United Arab Emirates (UAE) and is under regulatory review in the European Union. Outside of Japan and the UAE, the safety and efficacy of Dupixent in CSU remain under evaluation.
The potential new indication for CSU comes as Regeneron and Sanofi continue to expand Dupixent’s market presence. In September 2024, the FDA approved Dupixent for chronic obstructive pulmonary disease (COPD), marking its sixth indication and making it the first biologic approved for COPD. Dupixent is also approved for conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis.
Dupixent generated $11.3bn (€10.7bn) in global sales in 2023, as per Regeneron’s financials. Projections from GlobalData’s Pharma Intelligence Center suggest revenue could reach $23.6bn by 2030.
