Relovair COPD submissions on track despite mixed data

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it still plans to submit U.S. and EU regulatory applications mid-year for Relovair fluticasone furoate/vilanterol for chronic obstructive pulmonary disease (COPD) despite mixed Phase III data released Friday. GSK and partner Theravance Inc. (NASDAQ:THRX) said once-daily 250/50 ug Relovair met the primary endpoint of superiority to twice-daily 250/50 ug Advair fluticasone propionate/salmeterol in one trial, but missed the endpoint in a second, identical trial (p<0.001 and p=0.267, respectively). Each of the 12-week trials enrolled about 500 COPD patients and evaluated a primary endpoint of 24-hour weighted mean forced expiratory volume in one second (FEV1). Details were not disclosed. Theravance gained $0.85 to $19.47 on Friday.

Earlier this year, the partners said Relovair missed the primary endpoint of superiority to 500/50 ug Advair in a separate 12-week Phase III trial. Last year, the companies reported data from a pair of six-month Phase III trials showing that Relovair met five of the six co-primary endpoints (see BioCentury, Jan. 9). ...