CHMP recommends Nucala as adjunctive treatment for severe refractory eosinophilic asthma in children aged 6 to 17 years. - GSK.

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of mepolizumab (Nucala) from GlaxoSmithKline as adjunctive treatment for severe refractory eosinophilic asthma in children aged 6 to 17 years. 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.

Severe asthma that responds poorly to current standard-of-care asthma treatments has been reported in approximately 4.5% of children with asthma. The 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.

Comment: The FDA's Pulmonary-Allergy Drugs Advisory Committee voted on 25 July 2018 not to recommend mepolizumab as 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.