Press Release: Phase 3 study of Dupixent confirms significant improvements in pruritus and hives in patients with CSU

Dupixent Phase 3 study confirms significant improvements in pruritus and hives in patients with CSU

• This second pivotal study in biologic-naïve patients confirmed the results of CUPID-A and met primary and key secondary endpoints, showing that treatment with Dupixent resulted in a nearly 50 percent reduction in pruritus and urticaria activity scores compared to placebo.
• More than 300,000 people in the United States suffer from chronic spontaneous urticaria (CSU), which cannot be adequately controlled by antihistamines
• The data will support re-approval in the US by the end of the year; if approved, Dupixent would be the first targeted therapy for CSU in a decade

Paris and Tarrytown, NY, September 11, 2024. A confirmatory Phase 3 study of Dupixent (dupilumab) (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologically naive CSU receiving background antihistamine therapy. CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itching, which can impact quality of life. This positive study confirms the results from Study A, the first Phase 3 study of Dupixent in this context. Earlier this year, Japan became the first country in the world to approve and market Dupixent for adult and adolescent CSU patients based on the results from Study A.