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GSK submits EU filing for extended use of Relvar Ellipta

21 July 2017 14:26

GlaxoSmithKline and Innoviva has announced that they have submitted a filing to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI).

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.

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.

At 2:26pm: (LON:GSK) GlaxoSmithKline PLC share price was -2.25p at 1622.75p

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