GlaxoSmithKline plc (GSK) and biopharmaceutical company, Theravance, Inc. have submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).  GSK and Theravance announced the submission of a regulatory application for UMEC/VI for patients with COPD in the United States (US) on 18th December 2012 and in Europe on 9th January 2013.

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 (62.5/25mcg and 125/25mcg doses), with the proposed proprietary name Anoro Ellipta, has been submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW) as a maintenance bronchodilator treatment to relieve symptoms of obstructive airway disorder due to chronic obstructive pulmonary disease (COPD) (chronic bronchitis and emphysema).

GSK intends to commence global regulatory submissions for UMEC monotherapy later this year.

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 Ellipta and Breo Ellipta), 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 authorities.

Theravance  is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain.