GSK submits mepolizumab for U.S., EU approval

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) submitted a BLA to FDA and an MAA to EMA for mepolizumab ( SB-240563) as maintenance therapy for patients with severe eosinophilic asthma. The humanized IgG mAb against IL-5 is the first compound in its class to be submitted for regulatory approval.

GSK spokesperson Melinda Stubbee said the company plans to submit additional applications in Japan and unspecified territories in 2014 and 2015. ...