GlaxoSmithKline has announced that the European Commission has granted marketing authorisation for Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years.
As a result of this licence extension Nucala is now approved for use for severe refractory eosinophilic asthma in both adult and paediatric patients in the 31 European countries covered by the European Medicines Agency (EMA).
Nucala is the first and only approved biologic therapy for paediatric patients with severe asthma that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils.
“The availability of Nucala for young children with severe asthma, will provide control for these children and reassurance to their parents.”
There is a high unmet need in this population as the severity of disease is greater among children and adolescents than adults, and they are at greater risk of fatal or near-fatal events. Children are also in need of new treatment options as they currently have very limited options for severe asthma. In addition, long-term use of the current standard of care, oral corticosteroids, is associated with many of the adverse events observed in adults, with the additional burden of impaired growth in children.
Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy. Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs.
Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. Studies suggest that approximately 60% of patients with severe asthma have eosinophilic airway inflammation.
Dr Hal Barron, Chief Scientific Officer and President, Pharmaceuticals R&D, GlaxoSmithKline, said: “Asthma is the most common chronic disease in children. The availability of Nucala as the first targeted treatment available for young children with severe asthma, will help provide asthma control for these children and reassurance to their parents.”