Regeneron and Sanofi have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Dupixent (dupilumab) as a potential treatment for chronic spontaneous urticaria (CSU). Dupixent is under review for adults and adolescents aged 12 years and older who were not adequately controlled with the standard of care.
CSU causes hives that can cause severe itching and discomfort for patients. CSU is a debilitating condition that can significantly impact a patient's quality of life and has been associated with depression and anxiety. It is usually treated with H1 antihistamines.
The sBLA submission was based on data from two Phase 3 clinical trials, LIBERTY-CUPID Studies A and B. Studies A include patients who have uncontrolled CSU while on the standard of care and Study B includes patients who have uncontrolled CSU while on the standard of care and are refractory to Xolair.
Dupixent is a monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13). Dupixent is approved for treating atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps.