GSK/Theravance file GSK 573719 plus vilanterol at the FDA for COPD
GlaxoSmithKline plc (GSK) and Theravance, Inc. have announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with Chronic Obstructive Pulmonary Disease (COPD).
UMEC/VI is a combination of two investigational bronchodilator molecules -- GSK 573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA),administered using the ELLIPTA inhaler. The New Drug Application (NDA) for UMEC/VI (62.5/25mcg and 125/25mcg doses) has the proposed proprietary name ANORO ELLIPTA and has been submitted to the FDA, for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
Regulatory filings for UMEC/VI are planned in the European Union imminently and in other countries during the course of 2013. In addition, GSK intends to commence global regulatory submissions for UMEC monotherapy in the ELLIPTA inhaler for COPD patients in 2013.
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