Glaxo, Theravance Confirm Positive CHMP Opinion for Relvar Ellipta
GlaxoSmithKline plc (NYSE: GSK) (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today 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(TM) ELLIPTA(TM) for;
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". 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).
(c) 2013 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.