MAb Therapy Nucala's Approval Splits EU, US Regulatory Opinion On Age Range
This article was originally published in SRA
Executive Summary
European and US regulators have taken differing views on whether GlaxoSmithKline's new MAb therapy for severe eosinophilic asthma, Nucala (mepolizumab), should be indicated for use in adolescents, indicating that even after years of collaboration, they go their own way when making final decisions.