Trade Resources Industry Views GSK and Theravance Have Submitted a Regulatory Application in The US

GSK and Theravance Have Submitted a Regulatory Application in The US

GlaxoSmithKline (GSK) and Theravance have submitted a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, umeclidinium bromide (UMEC/VI), to treat chronic obstructive pulmonary disease (COPD) patients.

UMEC/VI is a combination of two investigational bronchodilator molecules, GSK573719 or UMEC, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler.

The companies have proposed proprietary name, ANORO ELLIPTA for UMEC/VI, a long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

In addition to commencing global regulatory submissions for UMEC monotherapy in the ELLIPTA inhaler for COPD patients in 2013, GSK is also planning future regulatory submissions for UMEC/VI in the European Union imminently and other countries in 2013.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/gsk-theravance-submit-umec-nda-to-fda-191212
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GSK, Theravance Submit UMEC NDA to FDA