GlaxoSmithKline plc (GSK) and Innoviva, Inc. announced a submission to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting ß2-agonist (LABA) combination, in patients already adequately controlled on an ICS/LABA combination.

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 ß2-agonist (SABA) and where use of a combination product (ICS and LABA) is appropriate. The proposed indication, would also include those patients already adequately controlled on an ICS/LABA combination.

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.

Based on review of the data from this study (201378), 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.

Full EU prescribing information is available at: EU Prescribing Information for Relvar Ellipta.

Following a 4-week open-label treatment period with FP/SAL 250/50 twice-daily, patients with well-controlled asthma were randomised to receive either FF/VI 100/25 once-daily, FP/SAL 250/50 twice-daily or FP 250 twice-daily in a double-blind, double-dummy manner for 24 weeks at multiple centres in 12 countries.

The primary objective of the study was to demonstrate non-inferiority of Relvar Ellipta 100/25 once-daily with Seretide Accuhaler 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent bronchial asthma, well-controlled on twice-daily ICS/LABA. The endpoint for the study was the change from baseline in clinic visit evening FEV1 (pre-bronchodilator and pre-dose) at the end of the 24-week treatment period.

To demonstrate the non-inferiority of FF/VI vs FP/SAL the lower limit of the 95% confidence interval for the mean difference in change from baseline for evening FEV1 needed to be greater than the pre defined margin of -100mL. This was to rule out the possibility that FF/VI was more than -100mL inferior to FP/SAL.