Monday, April 22, 2013

GSK and Theravance announce regulatory submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan

GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of 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. 

Japanese Submission: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)

Future Regulatory Submissions:  GSK intends to commence global regulatory submissions for UMEC monotherapy later this year.

Other Respiratory Development Programmes: 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.


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