The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of mepolizumab (Nucala, GlaxoSmithKline) as an adjunctive treatment for severe refractory eosinophilic asthma in children aged 6 to 17 years, according to a company news release.
Mepolizumab is a monoclonal antibody that decreases eosinophil maturation and survival by binding to interleukin-5 (IL5) and preventing it from interacting with the IL5 receptor, thereby reducing blood eosinophils.
If approved, it would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in pediatric patients in Europe, the company said in the statement.
"If approved, Nucala could provide an additional option for younger patients in Europe who still struggle to control their asthma despite taking inhaled steroids and other controller medications. These are patients who are at high risk of asthma attacks, which can be a very frightening experience for anyone, especially young children," Hal Barron said.
Severe asthma that responds poorly to current standard-of-care asthma treatments has been reported in approximately 4.5% of children with asthma, the company notes.
Approval of mepolizumab
The US Food and Drug Administration (FDA) approved mepolizumab for severe asthma with eosinophilic phenotype in patients aged 12 years and older in 2015 and for eosinophilic granulomatosis with polyangiitis in 2017.
The FDA's Pulmonary-Allergy Drugs Advisory Committee voted on July 25 not to recommend mepolizumab as an add-on treatment to reduce exacerbations in patients with chronic obstructive pulmonary disease guided by blood eosinophil counts, citing the need for more efficacy data.