GlaxoSmithKline and Theravance have announced that two Phase 3 studies have shown that COPD patients using the Incruse Ellipta umeclidinium (UMEC) DPI in conjunction with the Breo/Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI achieved a statistically significant greater improvement in FEV1 compared to patients using Breo/Relvar plus a placebo.
A total of 1238 COPD patients with FEV1 ≤70% participated in the two 12-week randomized, double-blind studies. Patients receiving Incruse got either a 62.5 mcg of UMEC or 125 mcg of UMEC. The 62.5 mcg dose is approved in the US, Canada, and Europe for the treatment of COPD; the 125 mcg dose is not approved in any country at this time.
GSK SVP and Head, Global Respiratory Franchise, Darrell Baker commented, “These data are an important addition to the evidence base supporting the efficacy and safety of Incruse. These studies are also the first to investigate the combined effect of two of the newest medicines from our respiratory portfolio, both of which provide 24 hour efficacy. We will continue to progress our research to expand our understanding of how the combined use of these medicines may provide physicians with another treatment approach to meet the individual needs of their patients.”
Read the GSK/Theravance press release.
