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.

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“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.” 

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