GSK’s subcutaneous injection Nucala (mepolizumab) is the first targeted biologic to be approved by the FDA for children from 6 years old to 11 years old with severe eosinophilic asthma. Approval comes on the back of an open-label study, conducted in children aged 6 to 11 years and suffering with the condition. The 52-week long-term phase of the study looked at Nucala’s pharmacokinetics, pharmacodynamics and long-term safety and showed that the safety profile in paediatric patients in this age bracket was similar to the known safety profile in patients aged 12 years and older.
Dr Daniel Jackson, Department of Paediatrics, University of Wisconsin, said: “Severe eosinophilic asthma in children is a complicated condition that can be extremely challenging to treat. Nucala has made a difference for many adults and adolescents living with severe asthma. This approval is an important development, giving physicians like me a much-needed option to consider for our paediatric patients”.
“FDA approves Nucala for paediatric eosinophilic asthma“
CEO and President, Allergy and Asthma Network, Tonya Winders, said: “As a mother of children who suffer from asthma, I know first-hand the huge impact it has on a family, from the constant worry about your child being hospitalised, to practical issues like arranging time off work to care for them. Having Nucala approved as the first biologic for treating severe eosinophilic asthma in this young age group represents a significant step forward for the asthma community.”
CSO and President, R&D, Dr Hal Barron, said: “Children with severe eosinophilic asthma currently have limited treatment choices available to them. We believe this important new indication for Nucala is a significant development for these children and their families”.