Pharmaceuticals giant GlaxoSmithKline (GSK) has revealed positive results from four pivotal phase III studies for its once-daily chronic obstructive pulmonary disease (COPD) treatment, LAMA/LABA (UMEC/VI.
GSK and Theravance studied some 4,000 patients with COPD through two 24-week efficacy studies that compared the combination LAMA/LABA, its components and placebo and two 24-week active comparator studies that compared the combination with the LAMA tiotropium, a widely prescribed maintenance bronchodilator for COPD.
GSK said that the results of the studies support its intention to commence global regulatory submissions for UMEC/VI from the end of 2012, ahead of schedule. This is subject to the successful completion of additional studies.
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"We are very encouraged by the results of these initial studies for our LAMA/LABA, an important cornerstone of our broad respiratory development portfolio," said Darrell Baker, SVP Respiratory Portfolio Optimisation Leader at GSK.
"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."
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