GlaxoSmithKline plc, (GSK,GSK.L), a research-based pharmaceutical and healthcare company and Theravance, Inc.(THRX), a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies, Monday announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare or MHLW, for the investigational once-daily long-acting muscarinic antagonist or LAMA/ a long-acting beta2 agonist or LABA combination medicine, UMEC/VI for patients with chronic obstructive pulmonary disease or COPD.
The companies also announced the submission of a regulatory application for UMEC/VI for patients with COPD in the United States on December 18, 2012 and in Europe on January 9, 2013.
A New Drug Application for UMEC/VI in 62.5/25mcg and 125/25mcg doses, with the proposed proprietary name ANORO ELLIPTA, has been submitted to the Japanese MHLW as a maintenance bronchodilator treatment to relieve symptoms of obstructive airway disorder due to COPD (chronic bronchitis and emphysema).
UMEC/VI is a combination of two investigational bronchodilator molecules - umeclidinium bromide, LAMA and vilanterol, LABA administered using the ELLIPTA inhaler.
GSK announced that it intends to commence global regulatory submissions for UMEC monotherapy later this year.
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