21 July 2017 - GSK and Innoviva today announced a submission to the EMA for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting β2-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 β2-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 reported 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.

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