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The European Commission (EC) has approved GlaxoSmithKline’s (GSK) Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
GlaxoSmithKline announced on Aug. 30, 2018 that the European Commission (EC) has granted marketing authorization for Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients six to 17 years old.
As a result of this license extension, Nucala is approved to treat severe refractory eosinophilic asthma in both adult and pediatric patients in the 31 European countries covered by the European Medicines Agency (EMA).
Nucala is a biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, GSK states. The drug, first approved by FDA in November 2015 for severe eosinophilic asthma, is a first-in-class monoclonal antibody believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood eosinophils.
In December 2017, FDA expanded approval of the drug to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication is the first agency-approved therapy specifically to treat EGPA, according to FDA. The drug is also approved as add-on maintenance treatment for EGPA in Japan and Canada.
GSK reports that the drug is currently being investigated for severe hypereosinophilic syndrome, nasal polyposis, and chronic obstructive pulmonary disease.