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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 applicat
ion for UMEC/VI for patients with COPD in the United States (US) on 18
December 2012 and in Europe on 9
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 beta
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)
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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