Research & Development
European Commission grants GlaxoSmithKline's Relvar Ellipta label update
12 March 2018 -

The European Commission has granted approval to United Kingdom-based GlaxoSmithKline for a label update for the use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS)/long-acting Beta2-agonist (LABA) combination, in patients whose asthma is already adequately controlled on both an inhaled corticosteroid and LABA, it was reported on Friday.

The Type II variation regulatory approval has been supported by data from a non-inferiority lung function study, which indicated that patients with adequately controlled asthma were able to switch to the once-daily FF/VI 100/25, from the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 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 FF/VI established in patients with asthma.

The updated marketing authorisation by the European Commission will be reflected in the label for Relvar Ellipta for countries in the European Union.



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