GlaxoSmithKline and Innoviva have asked the European Medicines Agency (EMA) to extend the use of Relvar Ellipta, a once-daily fluticasone furoate/vilanterol-based (FF/VI) inhaled corticosteroid (ICS) / combination, in patients already adequately controlled on an ICS/LABA combination.
As GSK notes in its Friday press release, FF/VI is currently indicated in Europe for the regular treatment of patients aged 12 and over with asthma who are not adequately controlled on both ICS and ‘as-needed’ short-acting β2-agonist (SABA) and where use of a combination product (ICS and long-acting β2-agonist – LABA) is appropriate. The proposed indication, would also include those patients already adequately controlled on an ICS/LABA combination, it has been pointed out in the press release.
According to GSK, the submission includes positive data from a previously reported1 non-inferiority lung function study which concluded that patients who have well-controlled asthma are able to switch from twice-daily fluticasone propionate/salmeterol, FP/SAL (Seretide Accuhaler) 250/50 to once-daily FF/VI 100/25, without compromising their lung function.
GSK added that, based on review of the data from this study, no new safety signals were identified and the adverse event data are consistent with the known safety profile for FF/VI established in patients with asthma. The study design was agreed with European regulatory authorities.