CHMP recommends Relvar Ellipta for COPD and Asthma

GlaxoSmithKline and Theravance, Inc. have announced that the European Medicines Agency�s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/vilanterol (FF/VI) under the proposed brand name Relvar Ellipta� for; 1.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 2.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�. Two strengths of FF/VI are proposed for asthma (92/22 mcg and 184/22 mcg) and one strength is proposed for COPD (92/22 mcg). All strengths will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI).