GlaxoSmithKline and Theravance have announced results from four Phase 3 studies of its umeclidinium bromide (UMEC)/vilanterol (VI) combination DPI for the treatment of COPD. The studies include two 24-week efficacy studies and two 24-week active comparator studies comparing UMEC/VI with tiotropium. UMEC is a a long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2 agonist (LABA).
Both efficacy studies showed statistically significant improvement in lung function for patients using UMEC/VI compared to placebo and to the individual components. The first of the comparator studies showed statistically significant improvement in lung function for two dosage levels of the combination compared to both VI alone and to tiotropium. The second comparator study showed a statistically significant improvement for the higher dose of the combination over tiotropium but not statistically significant improvements for the higher dose versus UMEC or the lower dose versus either UMEC or tiotropium.
GSK SVP Respiratory Portfolio Optimization Leader Darrell Baker said, “We are very encouraged by the results of these initial studies for our LAMA/LABA, an important cornerstone of our broad respiratory development portfolio. These studies, together with our earlier dose-ranging work, give us confidence that this is a once-daily medicine with the potential to benefit many patients with COPD. Subject to successful completion of the ongoing studies, we plan to commence global regulatory filings from the end of this year.”
Theravance CEO Rick E Winningham added, “There remains a great unmet medical need in COPD. In particular, physicians have stated that there is still a need to help patients breathe better. We believe the results of these initial studies demonstrate a potential benefit for patients with COPD.”
Read the GSK/Theravance press release.
