GlaxoSmithKline plc (GSK) and Theravance, Inc. have submitted 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 - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler.
A New Drug Application (NDA) for UMEC/VI (62.5/25 mcg and 125/25mcg doses) with the proposed proprietary name ANORO ELLIPTA has been submitted to the US Food and Drug Administration (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.
UMEC/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR and BREO), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK's investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab). These investigational medicines are not currently approved anywhere in the world.
ANORO, RELVAR, BREO and ELLIPTA are trademarks of the GlaxoSmithKline group of companies. The use of these brand names is not approved by any regulatory authority.
GlaxoSmithKline -- one of the world's leading research-based pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. The company is focused on the discovery, development and commercialisation of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain.