Posted by Michael Wonder on 09 Mar 2018
GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma
8 March 2018 - GlaxoSmithKline and Innoviva today announced that the European Commission has approved a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol), an inhaled corticosteroid/long-acting β2-agonist combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting β2-agonist.
The Type II variation regulatory approval has been supported by data from a non-inferiority lung function study, which demonstrated that patients with adequately controlled asthma were able to switch to the once-daily fluticasone furoate/vilanterol trifenatate 100/25, from the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol xinafoate) 250/50, without compromising their lung function.
No new safety signals were identified and the adverse event data were consistent with the known safety profile for fluticasone furoate/vilanterol trifenatate established in patients with asthma.
