Breo(GSK/Theravance)combination filed at FDA for COPD - 28-Sep-2012

GSK and Theravance, Inc. announced that the New Drug Application (NDA) for the once-daily investigational medicine, Breo (US)/Relvar (EU) (fluticasone furoate “FF”/vilanterol “VI” (FF/VI)) for patients with Chronic Obstructive Pulmonary Disease (COPD), has been accepted by the 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 12th May 2013.On 13th 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).