GlaxoSmithKline plc (GSK) and Theravance, Inc. have submitted a regulatory application in the European Union for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).
On December 18, 2012, both the companies have announced the submission of a regulatory application in the United States (US) for UMEC/VI.
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 Marketing Authorisation Application (MAA) for UMEC/VI (55/22mcg and 113/22mcg doses), with the proposed proprietary name ANORO, has been submitted to the European Medicines Agency (EMA) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. The UMEC/VI doses of 55/22mcg and 113/22mcg are specified as the delivered doses (emitted from the inhaler) which are equivalent to the 62.5/25mcg and 125/25mcg pre-dispensed doses (contained inside the inhaler) submitted for approval in the US.
Regulatory submissions for UMEC/VI are planned in other countries during the course of 2013. In addition, 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 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 authorities.
Theravance – is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies.