Theseus Pharmaceuticals Inc (THRX)

[surf1944]

7:11AM Theravance Announce and GlaxoSmithKline plc (GSK) regulatory submission for UMEC/VI (LAMA/LABA) in the US (THRX) 22.08 : GlaxoSmithKline plc (GSK) and Theravance (THRX) announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).

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, administered using the ELLIPTA inhaler.

US Submission:
A New Drug Application for UMEC/VI (62.5/25mcg and 125/25mcg doses) with the proposed proprietary name ANORO ELLIPTA has been submitted to the US Food and Drug Administration, for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

Future Regulatory Submissions:
Regulatory filings for UMEC/VI are planned in the European Union imminently and in other countries during the course of 2013. In addition, GSK intends to commence global regulatory submissions for UMEC monotherapy in the ELLIPTA inhaler for COPD patients in 2013.