GlaxoSmithKline’s Nucala has been approved for use in paediatric patients with severe eosinophilic asthma.
The European Commission has granted the biologic marketing authorisation as an add-on treatment for severe refractory eosinophilic asthma in patients aged six up to 17 years.
The move gives patients of this age access to a biologic that targets IL-5, which plays an important role in regulating the function of eosinophils, for the first time.
“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,” said Dr Hal Barron, chief scientific officer and president, Pharmaceuticals R&D, at GSK.
Nucala was approved for use in adults in 2015, on the back of data showing that the drug cut the frequency of clinically significant exacerbations of asthma by 47% versus placebo, while the 100mg dose cut the amount by 53%.
Earlier this year the firm also released long-term data showing that its biologic significantly decreased exacerbations in patients with severe, eosinophilic asthma as well as improvement in disease control.
According to the results, from the COLUMBA trial, one third of patients treated with Nucala (mepolizumab) experienced no exacerbations at all, despite entering the study with an average of almost two exacerbations (1.74) per year.
The data also showed an overall 61% decrease in exacerbation rate, and an 8% reduction in blood eosinophils (which cause inflammation in certain people with severe asthma).
Around 60% of patients with severe asthma are thought to have eosinophilic airway inflammation.
