GSK and Theravance have announced a Phase 3 study of fluticasone furoate (FF)/vilanterol (VI) (the Relvar Ellipta DPI) including Japanese COPD patients. In July 2013, GSK withdrew its application for Relvar for the treatment of COPD in Japan because the available Japanese patient data at the time showed that the FF component failed to produce a statistically significant improvement in lung function.
Relvar Ellipta was approved for asthma in Japan in September 2013.
The new 12-week study looks to include approximately 350 Japanese COPD patients out of 1580 total patients. According to the companies, “Demonstration of a statistically significant contribution of FF 100mcg to the combination on lung function needs to be shown in this study, with a trend demonstrating a positive benefit in the Japanese patients sub-group, being pivotal for the approval of FF/VI 100/25mcg for treatment of COPD in Japan.”
Read the GSK/Theravance press release.
