Relvar Ellipta is a combination inhaler containing 2 active ingredients not previously available: fluticasone furoate (an inhaled corticosteroid [ICS]) and vilanterol (a long-acting beta2 agonist [LABA]). These are administered using the multi-dose, dry powder Ellipta inhalation device (GlaxoSmithKline: personal communication March 2013).
Fluticasone furoate/vilanterol (Relvar Ellipta, GlaxoSmithKline) was submitted to the European Medicines Agency (EMA) for evaluation for a marketing authorisation for the symptomatic treatment of chronic obstructive pulmonary disease (COPD) in adults with a FEV1 (forced expired volume in 1 second) of less than 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy. A marketing authorisation for the use of this product in asthma has also been submitted. Evidence on the potential use of this product in asthma is not reviewed in this evidence summary.
The manufacturer expects a final authorisation decision by late 2013.
The proposed dose is fluticasone furoate 100 micrograms plus vilanterol 25 micrograms once daily, which if approved will be licensed as fluticasone furoate 92 micrograms plus vilanterol 22 micrograms (dose delivered using the mouth piece of the device) (GlaxoSmithKline: personal communication March 2013).
The exact dose equivalence between fluticasone furoate and fluticasone propionate (the currently licensed fluticasone salt) is not known (GlaxoSmithKline: personal communication May 2013).
The cost of Relvar Ellipta is yet to be determined (GlaxoSmithKline: personal communication March 2013).