GlaxoSmithKline and Theravance file for EU approval of UMEC/VI for COPD

10 January 2013

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) yesterday submitted a regulatory application in the European Union for their investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD) under the proposed proprietary name Anoro. Theravance’s shares closed up 4.5% at $22.69 yesterday, while GSK advanced 0.5% to £13.81.

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(2) agonist (LABA), administered using the Ellipta inhaler.

Last month, GSK and Theravance announced the submission of a regulatory application in the USA for UMEC/VI, for patients with COPD (The Pharma Letter December 19, 2012). A Prescription Drug User Fee Act (PDUFA) goal date has been confirmed as May 12, 2013.

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