PARIS (dpa-AFX) - Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi SA (SNY) on Monday said the European Commission has approved Dupixent for treating moderate-to-severe chronic spontaneous urticaria (CSU) in children aged 2 to 11 years who have an inadequate response to histamine-1 antihistamines and have not previously received anti-immunoglobulin E therapy.
The decision expands the drug's existing EU approval, which previously covered adults and adolescents aged 12 years and older with CSU, a chronic inflammatory skin disease marked by recurrent hives and intense itching.
The approval is based on data from the LIBERTY-CUPID clinical program, including efficacy results from two Phase 3 studies in adults, along with pharmacokinetic, safety, and efficacy data from the CUPIDKids Phase 3 trial in children.
Results showed that Dupixent significantly reduced overall urticaria activity-measuring both itch and hives-as well as individual symptom severity versus placebo at 24 weeks. The treatment also increased the proportion of patients achieving well-controlled disease and complete response compared with placebo.
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
