GlaxoSmithKline plc GSK GSK and Theravance, Inc.
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).
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