Nucala is the only targeted biologic in the US to receive FDA approval for treating eosinophilic asthma in children aged between six and 11 years
Image: FDA approves use of GSK’s Nucala for young children with severe eosinophilic asthma. Photo: Courtesy of Arek Socha from Pixabay.
UK-based multinational pharmaceutical company GlaxoSmithKline (GSK) has received the US Food and Drug Administration (FDA) approval for the use of Nucala (mepolizumab) in children aged between six and 11 years with severe eosinophilic asthma.
Severe asthma is a condition that requires treatment composed of inhaled corticosteroids (ICS), along with a second controller or systemic corticosteroids in high dose, to prevent the disorder from turning uncontrolled.
Allergy and Asthma Network CEO and president 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.”
Nucala is the only targeted biologic in the US to receive FDA approval for treating eosinophilic asthma in children aged between six and 11 years.
According to the company, the FDA approval is based on an open-label study that investigated Nucala’s pharmacokinetics, pharmacodynamics and long-term safety for the treatment of children with severe eosinophilic asthma.
In addition, results from well-controlled trials in adults and adolescents, along with the 52-week long-term phase of the study, showed that the safety profile in paediatric patients aged six to 11 years was similar to the known safety profile in patients aged 12 years and older.
GSK R&D president and chief scientific officer 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.”
FDA first approved Nucala – mepolizumab 100mg in 2015
GSK said that Nucala is the monoclonal antibody that targets IL-5, which is believed to prevent IL-5 from binding to its receptor on the surface of eosinophils, preventing depletion of blood eosinophils.
Nucala is currently approved as an add-on maintenance treatment in a100mg dose of mepolizumab subcutaneous injection for patients aged 12 years and older with severe eosinophilic asthma.
The approval is now extended to patients aged six to 11 years in 40mg dose subcutaneous injection. Nucala 300mg administered as three separate 100mg subcutaneous injections of mepolizumab is approved for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
University of Wisconsin paediatrics department professor Daniel Jackson 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.”