FDA Expands Dupilumab for EoE to Younger Children

The FDA has approved dupilumab for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. Dupilumab is the first and only medicine approved for this use. EoE is a chronic inflammatory disorder that damages the esophagus, causing difficulty swallowing and eating. The approval is based on results from a phase 3 trial, which showed that 66% of children who received higher dose dupilumab achieved disease remission, compared to 3% of those who received a placebo. The most common adverse events were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.

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