GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) said Tuesday that the New Drug Application (NDA) for a investigational combination medicine to treat patients with chronic obstructive pulmonary disease (COPD) has been accepted by the U.S. Food and Drug Administration.
The acceptance of the NDA indicates that the application is sufficiently complete to permit a substantive review, and a target date of December was set for possible market approval.
In December 2012 and January 2013, GSK and Theravance said regulatory applocations had been made in both the U.S. and Europe.
UMEC/VI, with proposed brand name ANORO, 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 ELLIPT inhaler.
GSK operates its North American headquarters in RTP.
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