Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

This article describes how a model-informed drug development (MIDD) approach was used to support the development of nemolizumab for patients with moderate-to-severe atopic dermatitis. Instead of relying only on traditional clinical trials, researchers combined data from multiple studies with advanced modeling to better understand how the drug behaves in the body and how it affects patients. These models helped predict the most effective and safe dosing for both adults and adolescents, even when direct clinical data were limited. Overall, the study shows that using modeling and simulation can improve decision-making, optimize dose selection, and potentially speed up drug development while reducing the need for additional trials.