GSK and Theravance announce FDA acceptance of FF/VI NDA submission in the US for COPD

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 12May 2013.

On 13July 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 25September 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).

FF/VI is administered by a new dry powder inhaler called Ellipta™.  FF/VI has the proposed brand name Relvar™ in Europe and Japan and Breo™ in the US.  FF/VI is an investigational medicine and is not currently approved anywhere in the world.  Relvar™, Breo™ and Ellipta™ are trademarks of the GlaxoSmithKline group of companies. The use of these brand names has not yet been approved by any regulatory authority.