GSK/Innoviva COPD combo passes Phase III test

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) said fluticasone furoate/umeclidinium/vilanterol met the co-primary endpoints in the Phase III FULFIL study to treat chronic obstructive pulmonary disease. GSK expects to submit regulatory applications for the candidate in the U.S. and EU by YE16.

The combination significantly improved lung function vs. Symbicort Turbuhaler budesonide/formoterol as measured by trough forced expiratory volume in one second (FEV1) (p<0.001) and quality of life scores on the St. George's Respiratory Questionnaire (p<0.001) after 24 weeks, meeting both primary endpoints. ...