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GSK And Theravance Announce FDA Acceptance Of FF/VI New Drug Application (NDA) Submission In The US For COPD

LONDON and SOUTH SAN FRANCISCO, Calif., Sept. 26, 2012 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (GSK) and Theravance, Inc. (Nasdaq:THRX) today announced that the New Drug Application (NDA) for the once-daily investigational medicine fluticasone furoate "FF"/vilanterol "VI" (FF/VI) for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the US 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 12 th May 2013.

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On 13 th July 2012, GSK and Theravance announced the submission by GSK of regulatory applications in the US and European Union for FF/VI for patients with COPD and a regulatory application for asthma in the European Union. The Marketing Authorisation Application (MAA) for FF/VI for COPD and asthma has been validated by the European Medicines Agency (EMA).

GSK also submitted a Japanese New Drug Application (JNDA) for FF/VI for patients with COPD and asthma on 25 th September 2012.

FF/VI is one of several late-stage assets in the GSK respiratory development portfolio, which also includes the investigational LAMA/LABA combination umeclidinium bromide/vilanterol (UMEC/VI), 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).

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