FDA Set To Review Dupixent® For Chronic Spontaneous Urticaria, A Potential Breakthrough For Patients

Regeneron Pharmaceuticals and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as a treatment for chronic spontaneous urticaria (CSU) in adults and children aged 12 and older who are not responding well to H1 antihistamine therapy. The FDA is expected to make a decision by April 18, 2025.

The resubmitted supplemental Biologics License Application (sBLA) for Dupixent® in chronic spontaneous urticaria (CSU) is backed by data from the LIBERTY-CUPID Phase 3 clinical program, which includes Studies A, B, and C. Study C, the latest trial conducted on patients with uncontrolled CSU who were receiving standard antihistamine treatment, adds to the previously submitted data. 

This pivotal trial met its primary and secondary endpoints, confirming the positive results from Study A, showing that Dupixent® significantly alleviated itch and hives. Safety data across all LIBERTY-CUPID trials remained consistent with Dupixent's known safety profile, with the most common adverse events (≥5%) being injection site reactions and COVID-19 infections.