GlaxoSmithKline plc and Theravance Inc. announced positive results from two Phase 3 studies, which showed that patients with chronic obstructive pulmonary disease (COPD) who received the anticholinergic, Incruse Ellipta (umeclidinium [UMEC] 62.5mcg), or umeclidinium 125mcg (an unlicensed dose) in addition to Relvar/Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]), an inhaled corticosteroid/long-acting beta2-agonist combination, achieved an additional improvement in lung function (FEV1) compared to patients receiving FF/VI plus placebo.

 

The studies showed that for the primary endpoint of trough FEV1 at Day 85, the addition of UMEC 62.5mcg or UMEC 125mcg to FF/VI 100/25mcg resulted in a statistically significant improvement in lung function when compared with FF/VI 100/25mcg plus placebo in patients with COPD.

 

Darrell Baker, SVP and head, global respiratory franchise, GSK, said: “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.”

 

“We are pleased with the positive data from these two studies evaluating an open triple therapy, Incruse added to Relvar/Breo Ellipta,” said Rick Winningham, chief executive officer, Theravance. “With the data reported today, we have further strengthened our understanding of Relvar/Breo Ellipta.”

 

Date: June 11, 2014

Source: GSK