Posted by Michael Wonder on 30 Aug 2018
European Commission approves Nucala (mepolizumab) for the treatment of children with severe asthma
30 August 2018 - First anti-IL-5 biologic treatment for paediatric patients with severe eosinophilic asthma in Europe.
GlaxoSmithKline today announced that the European Commission has granted marketing authorisation for Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. As a result of this licence extension Nucala is now approved for use for severe refractory eosinophilic asthma in both adult and paediatric patients in the 31 European countries covered by the EMA.
This marketing authorisation is based on a partial data extrapolation approach which was agreed with the paediatrics committee 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.
