Sanofi: Dupixent Receives Unprecedented Pediatric Approval in the United States
The United States Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for treating chronic spontaneous urticaria in children aged two to eleven years who remain symptomatic despite treatment with H1 antihistamines. This extension marks the first approval of a biologic drug for this pediatric indication in the United States.
Expansion of Dupixent's Approval
Dupixent, jointly developed by Sanofi and Regeneron, extends its existing approval for adults and adolescents aged 12 and older with chronic spontaneous urticaria (CSU). This new indication targets children aged two to eleven years who remain symptomatic despite treatment with H1 antihistamines. The drug inhibits the signaling of interleukins IL-4 and IL-13, two key factors in type 2 inflammation contributing to this disease. According to Sanofi, over 14,000 children aged two to eleven in the United States suffer from uncontrolled CSU with few alternative therapeutic options.
Basis for Approval
The approval is primarily based on the LIBERTY-CUPID study program, which includes two replicated phase 3 studies (Studies A and C) conducted in patients aged six years and older, and the single-arm phase 3 CUPIDKids study in children aged two to eleven years. In Studies A and C, Dupixent significantly reduced the severity of itching and urticaria activity compared to placebo at week 24, and increased the likelihood of good disease control or a complete response in adults and adolescents. The safety profile in children aged two to eleven years was consistent with that observed in other approved dermatological indications. The most common adverse reaction (? 2%) was an injection site reaction. No new adverse reactions were identified in children of this age group treated with Dupixent.
