GSK and Theravance have submitted their new chronic obstructive pulmonary disease (COPD) maintenance therapy to EU regulators for approval, hot on the heels of a filing in the US last month.
The once-daily inhaler UMEC/VI, which the companies hope to market as Anoro, is a combination of the long-acting muscarinic antagonist (LAMA) umeclidinium bromide and the long-acting beta-agonist (LABA) vilanterol – coded UMEC/VI by the firms.
The companies are seeking clearance from the European Medicines Agency to market the product as a maintenance bronchodilator treatment for the relief of symptoms in adult patients with COPD.
Last summer, the drugmakers unveiled data from Phase III clinical trials showing that UMEC/VI induced statically significant improvements in COPD symptoms versus its individual components and placebo.
At the time, Darrell Baker, SVP Respiratory Portfolio Optimisation Leader at GSK, said “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”.
Regulatory submissions for UMEC/VI are planned in other countries in 2013, and GSK also said it intends to kick off global regulatory submissions for UMEC as a monotherapy sometime in the year.
