Sanofi and Regeneron's Dupixent gains EU approval for chronic spontaneous urticaria
The European Commission has approved Sanofi and Regeneron's Dupixent (dupilumab) as the first targeted therapy in the EU for chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who have an inadequate response to antihistamines.
The European Commission has approved Sanofi and Regeneron's Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and older. The approval is for patients who have not responded adequately to histamine-1 antihistamines (H1AH).
Dupixent represents the first targeted medicine approved in the EU for CSU in over a decade. The drug works by inhibiting IL-4 and IL-13, two key drivers of type 2 inflammation, which are central to CSU.
The decision is based on Phase 3 clinical trial data from the LIBERTY-CUPID program. Studies showed that Dupixent significantly reduced itch and hives compared to placebo at 24 weeks, leading to better overall disease control for patients.
Approximately 270,000 adults and adolescents in the EU live with CSU, often remaining symptomatic despite standard antihistamine treatment. Dupixent is already approved for seven other chronic inflammatory diseases within the EU.