The Food and Drug Administration (FDA) has approved Nucala (mepolizumab; GlaxoSmithKline) as an add-on maintenance treatment for patients 6 to 11 years old with severe eosinophilic asthma. Previously, the biologic treatment had been indicated for patients over 12 years of age.
Nucala is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa). Approval in this younger patient population was supported by evidence from clinical trials in adults and adolescents. In addition, findings from an open-label trial evaluating the pharmacokinetics, pharmacodynamics, and safety of Nucala in patients 6 to 11 years old (N=36) showed that a dose of 40mg administered subcutaneously (SC) every 4 weeks resulted in similar drug exposure as a dose of 100mg SC in adults and adolescents.
Nucala injection is intended for use under the guidance of a healthcare professional. The product is available in 100mg single-dose vials for reconstitution and in 100mg/mL single-dose prefilled autoinjectors and glass syringes; the prefilled autoinjector and syringe are only for use in adults and adolescents aged 12 years and older.
“Children with severe eosinophilic asthma currently have limited treatment choices available to them,” said Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK. “We believe this important new indication for Nucala is a significant development for these children and their families.”
For more information visit gsk.com.