FDA To Review Supplemental Biologics Application for Dupixent for Chronic Spontaneous Urticaria 

Regeneron Pharmaceuticals and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) for chronic spontaneous urticaria (CSU).

The sBLA is indicated for adults and children aged 12 years and above for which their CSU is not being adequately controlled by H1 antihistamines, which is currently the standard of care for the condition.

CSU is an inflammatory skin condition causing sudden hives and swelling, usually to the face, hands, and feet. However, in some cases, it can also affect the throat and upper airways. Despite the use of H1 antihistamines, up to 50% of patients are not seeing effective relief from the condition. These individuals are therefore left with very limited options, many suffering a significant decrease in quality of life.

The FDA accepted the review based on data from two phase 3 trials, LIBERTY-CUPID Studies A and B. During Study A, Dupixent® was added to the standard-of-care antihistamines, which almost doubled the reduction in itch and urticaria activity compared to placebo. Results showed a 63% reduction in itch severity with Dupixent® compared to 35% with placebo. It also demonstrated a 65% reduction in urticaria activity severity compared to placebo’s 37%.

Regeneron Pharmaceuticals and Sanofi reveal the target action date for the FDA decision as October 22, 2023.


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