Dupixent (Dupilumab) Advances Towards FDA Approval for Chronic Spontaneous Urticaria (CSU) in 2025

FDA Review Initiated:
The FDA has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older whose disease is not adequately controlled with H1 antihistamine treatment1.

Clinical Trial Results:
The LIBERTY-CUPID Phase 3 study program demonstrated that Dupixent significantly reduced itch and urticaria activity (itch and hives) in patients with CSU, providing new hope for those with inadequately controlled disease1 2.

Target Population:
Over 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines, making Dupixent a potential treatment option for this significant patient population1 4.

Expected FDA Decision:
The FDA decision on the sBLA is expected by April 18, 2025. If approved, Dupixent would be the first targeted therapy for CSU in a decade1.

Regulatory Background:
This resubmission follows an FDA rejection last year, with new pivotal data from the LIBERTY-CUPID Phase 3 study program included in the application2 5.

Global Use:
Dupixent has received regulatory approvals in more than 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and COPD, with over 1,000,000 patients currently being treated globally1 3.