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biotech/news//Medical Xpress
Sanofi and Regeneron's Dupixent (dupilumab) approved for children with chronic spontaneous urticaria.
The FDA approved Dupixent for children aged 2 to 11 years with chronic spontaneous urticaria.
KEY POINTS
Dupixent is now the first biologic approved for CSU patients as young as 2 years old.
Approval was based on efficacy and pharmacokinetic data from the Phase III CUPIDKids study in children.
Dupixent significantly reduced itch severity and urticaria activity versus placebo in clinical studies.
The U.S. Food and Drug Administration has approved Sanofi and Regeneron's Dupixent (dupilumab) for the treatment of children (aged 2 to 11 years) with chronic spontaneous urticaria (CSU).
This approval expands the previous approval for adults and adolescents ages 12 years and older with CSU who remain symptomatic despite histamine-1 antihistamine treatment. The fully human monoclonal antibody is administered as a subcutaneous injection.
Data from the LIBERTY-CUPID clinical study program informed the approval, which included efficacy and safety data from two Phase III studies (study A and study C) in adults and adolescents aged 12 years and older with CSU, as well as pharmacokinetics data from the CUPIDKids Phase III study in children aged 2 to 11 years with CSU.
Results from study A and study C showed that Dupixent significantly reduced itch severity and urticaria activity (a composite of itch and hives) versus placebo at week 24 and also increased the likelihood of well-controlled disease or complete response versus placebo. The safety of Dupixent was supported by data from pediatric patients in other indications.
"Dupixent is the first biologic approved for patients as young as 2 years of age, offering a targeted approach that inhibits IL-4 and IL-13 signaling, two key and central drivers of the type 2 inflammation that contributes to this disease," Alyssa Johnsen, M.D., Ph.D., from Sanofi, the manufacturer of Dupixent, said in a statement.
"Until now, these patients had to rely on limited treatment options that didn't address potential critical mediators of chronic spontaneous urticaria."