Mepolizumab as an add-on therapy for paediatric asthmaOctober 10, 2018
Mepolizumab (Nucala) has been cleared for marketing by EC as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years.
Mepolizumab is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, GSK said.
Mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is 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. The drug was first approved in 2015 for severe eosinophilic asthma,
Mepolizumab has been studied in over 3,000 patients in 16 clinical trials across a number of eosinophilic indications and has been approved in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with severe eosinophilic asthma.
In the US, Japan and Canada, it is approved as add-on maintenance treatment for patients with eosinophilic granulomatosis with polyangiitis (EGPA). Mepolizumab is currently being investigated for severe hypereosinophilic syndrome, nasal polyposis and COPD.
This marketing authorisation is based on a partial data extrapolation approach which was agreed with the paediatrics committee (PDCO) of the EMA. With this approach, efficacy and safety data from the Phase III studies included in the mepolizumab severe asthma development programme for patients 12 and over were extrapolated to children.