FDA to Review Dupixent for Chronic Spontaneous Urticaria
Key Insights
The FDA has accepted Sanofi and Regeneron's sBLA for Dupixent (dupilumab) to treat chronic spontaneous urticaria (search) (CSU) in adults and children aged 12 and above.
The target action date is April 18, 2025, and if approved, Dupixent could be the first targeted CSU therapy in a decade.
The sBLA is based on Phase III LIBERTY-CUPID program findings, where Dupixent significantly reduced itch and urticaria activity in patients inadequately controlled by antihistamines.
The FDA has accepted for review Sanofi and Regeneron's supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (search) (CSU) in adults and children aged 12 years and older whose condition persists despite treatment with H1 antihistamines. The FDA has set a target action date of April 18, 2025.
If approved, Dupixent is poised to become the first targeted CSU therapy in ten years, addressing a significant unmet need for patients who do not respond to existing treatments. The resubmitted sBLA is supported by data from the Phase III LIBERTY-CUPID clinical program, which includes Study A, Study B, and Study C.
LIBERTY-CUPID Phase III Trial Details
Studies A and C of the LIBERTY-CUPID program focused on CSU patients whose symptoms were inadequately controlled by antihistamines. Study B included patients who were unresponsive to both antihistamines and omalizumab. Study C, a pivotal trial within the program, met its primary and key secondary endpoints, demonstrating that Dupixent significantly reduced itch and urticaria activity, mirroring the outcomes observed in Study A.
The safety profile of Dupixent in these trials was consistent with its known safety profile across other approved indications. Adverse events reported in the Phase III trials aligned with Dupixent’s established safety profile. Injection site reactions and COVID-19 were the most frequently reported adverse events in patients treated with Dupixent, occurring in at least 5% of cases.
Dupixent's Global Presence
Dupixent has already been approved for various indications in over 60 countries, including atopic dermatitis and asthma, across different age groups. For CSU specifically, it has received approval in Japan and the United Arab Emirates (UAE), with a regulatory review currently underway in the European Union.
Sanofi and Regeneron Pharmaceuticals are co-developing Dupixent and are currently investigating its potential in treating a wide array of conditions linked to type-2 inflammation or allergic processes in ongoing Phase III trials.