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.
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).