GSK and Theravance have announced that results from three phase 3 studies comparing the Anoro Ellipta umeclidinium/vilanterol DPI to Advair and Seretide Diskus in COPD patients show greater improvement in lung function for patients treated with Anoro Ellipta. The three randomized, double-blind, double-dummy, parallel group studies involved a total of about 2,100 patients.
GSK Senior VP and Head, Global Respiratory Franchise Darrell Baker commented, “We are pleased to communicate these data comparing the effect of these treatments on the lung function of patients with COPD who do not have a history of exacerbations. These findings add to the existing body of evidence and our understanding of the efficacy and safety of UMEC/VI.”
Theravance CEO Rick E. Winningham added, “We are pleased to announce the results from these positive studies, which provide physicians with further data regarding UMEC/VI as a treatment option for appropriate patients with COPD.”
Anoro Ellipta was approved by the FDA in December 2013. Canada approved the inhaler the same month. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Anoro in February 2014.
The companies said that complete results of three studies will be available on clinicaltrials.gov and that they will also present results at a scientific meeting.
Read the GSK and Theravance press release.