The Enlightenment of Pediatric Clinical Research on Dupilumab Injection for Drug Development in Children in China
Atopic dermatitis occurs in adults and pediatric populations of all ages.Dupilumab injection is the first fully humanized immunoglobulin G4(IgG4)subtype monoclonal antibody against targeting the interleukin-4 receptor subunit α(IL-4Rα),used to treat varying degrees of atopic dermatitis in both adults and children.This article reviews the development process and clinical pharmacology studies of dupilumab injection for pediatric atopic dermatitis indications.The product development strategy involved a stepwise,age-sequential approach,starting from older children to younger age groups.Multiple pediatric clinical studies were carried out progressively,utilizing pediatric exposure data to match adult exposure and combining exposure-effect analyses for dose selection in pediatric patients.The current progress and status of the development of pediatric atopic dermatitis indications in China were also analyzed,aiming to provide references for domestic pediatric drug development.
万方数据
维普
