GSK and Theravance announce FDA acceptance of NDA submission in the US for ANORO ELLIPTATM for COPD

Posted: 19 February 2013 | | No comments yet

The NDA for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI has been accepted…

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GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as 18 December 2013.

In December 2012 and January 2013, GSK and Theravance announced the submission by GSK of regulatory applications in the United States and the European Union, respectively, for UMEC/VI for patients with COPD. The Marketing Authorisation Application (MAA) for UMEC/VI has been validated for assessment by the European Medicines Agency (EMA).

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 ELLIPTA™ inhaler.

Future regulatory submissions:

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, administered using the ELLIPTA™ inhaler, for COPD patients later this year.

Other respiratory development programmes:

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.

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