Sanofi: Sanofi and Regeneron's Dupixent approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria
The US FDA has approved Dupixent for children aged 2-11 with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. The approval is based on data from the LIBERTY-CUPID clinical study program.
The US Food and Drug Administration has approved Dupixent (dupilumab) for children aged 2-11 with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine treatment. This expands the previous approval for Dupixent in adults and adolescents aged 12 years and older with CSU. The approval is based on data from the LIBERTY-CUPID clinical study program, which includes extrapolation of efficacy and safety data from phase 3 studies in adults and adolescents, complemented with pharmacokinetics data from a phase 3 study in children aged 2-11. Dupixent significantly reduced itch severity and urticaria activity compared to placebo at Week 24 in adults and adolescents. The safety results were generally consistent with the known safety profile of Dupixent in its approved dermatological indications.
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