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news.The US Food and Drug Administration (FDA) has accepted GlaxoSmithKline (GSK) and Theravance's New Drug Application (NDA) for fluticasone furoate FF/vilanterol VI ( FF/VI).
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The once-daily investigational medicine FF/VI is used to treat chronic obstructive pulmonary disease (COPD).
The Marketing Authorisation Application for FF/VI for COPD and asthma has also been validated by the European Medicines Agency (EMA), according to Theravance.
FF/VI developed by GSK also includes the investigational LAMA/LABA combination umeclidinium bromide/vilanterol, VI monotherapy and MABA developed along with Theravance and GSK’s investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb.
FF/VI, called as Relvar in Europe and Japan, and Breo in the US, is delivered using dry powder inhaler called Ellipta.
GSK submitted regulatory applications for FF/VI on 13 July 2012 in the US and European Union along with Japanese New Drug Application on 25 September 2012.