CHMP backs GSK's asthma therapy

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said EMA's CHMP recommended marketing authorization for Nucala mepolizumab ( SB-240563) as an add-on treatment for severe refractory eosinophilic asthma in adults. The company expects a final decision from the European Commission by YE15.

The humanized IgG mAb against IL-5 is also under FDA review with a Nov. 4 PDUFA date. In June, an FDA committee voted 14-0 that efficacy and safety data support approval of mepolizumab to treat severe asthma with eosinophilic inflammation in adults. The committee voted 10-4 that data do not support the compound's approval in children aged 12-17 (see BioCentury Extra, June 11). ...