Mepolizumab regulatory update

GlaxoSmithKline submitted a BLA to FDA and an MAA to EMA for mepolizumab as a maintenance treatment for severe eosinophilic asthma in patients with a history of exacerbations. The BLA covers patients ages >=12 years with a history of exacerbations, and the MAA covers add-on treatment in adult patients with a history of exacerbations and/or dependency on systemic corticosteroids. The humanized IgG mAb against IL-5 is the first compound in its class to be submitted for regulatory approval. GSK plans to submit applications in Japan and elsewhere in 2014 and 2015. ...