EU approves Relvar Ellipta (GSK) for Asthma and COPD

GlaxoSmithKline plc and Theravance, Inc. announced that the European Commission has on 18 November 2013, granted marketing authorisation for Relvar Ellipta,(fluticasone furoate plus vilanterol) which is now licensed across 31 European countries for the following uses: -Asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate: -patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists. COPD: the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.>

Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate �FF�, and the long-acting beta2-agonist (LABA), vilanterol �VI� (FF/VI). Two strengths of FF/VI have been licensed for the treatment of asthma (92/22 mcg and 184/22 mcg) and one strength has been licensed for the treatment of COPD (92/22 mcg). Both strengths will be administered once-daily using Ellipta, a new dry powder inhaler (DPI)