GSK Submits EU Filing For Extended Use Of Relvar Ellipta

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Innoviva Inc. (INVA) announced a submission to the European Medicines Agency for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid pr ICS / long-acting ß2-agonist or 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.