Sanofi Announces FDA Acceptance of sBLA for Dupixent in Chronic Spontaneous Urticaria

Intelligent Finance APP learned that Sanofi S.A. (SNY.US) announced the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Dupixent, intended for treating adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who are inadequately controlled under current standard of care. The FDA’s target action date is October 22, 2023. Data from two Phase III clinical trials supported the sBLA, assessing the efficacy of Dupixent in two distinct CSU patient populations.

Dupilumab was jointly developed by Regeneron and Sanofi. The two companies are also conducting a Phase 3 clinical trial studying Dupixent for the treatment of chronic allergic urticaria triggered by the common cold.