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.
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