GlaxoSmithKline plc, one of the world’s leading research-based pharma and healthcare companies, and a biopharma company with a pipeline of internally discovered product candidates - Theravance, Inc. jointly announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/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 December 18, 2013.
In December 2012 and January 2013, GSK and Theravance announced the submission by GSK of regulatory applications in the United States and the European Union, respectively, for UMEC/VI for patients with COPD. The Marketing Authorisation Application (MAA) for UMEC/VI has been validated for assessment by the EMA.
UMEC/VI, with proposed brand name ANORO, is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler.
UMEC/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR and BREO), 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). These investigational medicines are not currently approved anywhere in the world.
ANORO, RELVAR, BREO and ELLIPTA are trademarks of the GSK group of companies. The use of these brand names is not approved by any regulatory authorities.