GSK submits application to allow use of Relvar Ellipta for adequately controlled asthma

GlaxoSmithKline and Innoviva have announced the filing of a submission to the EMA for the use of the Relvar Ellipta fluticasone furoate/vilanterol DPI (marketed as Breo Ellipta in the US) by patients whose asthma is adequately controlled with the use of an ICS/LABA combination.

Relvar Ellipta was approved in the EU for the treatment of asthma not adequately controlled by ICS/LABA therapy in 2013.

According to GSK, data from a study announced earlier this year demonstrating non-inferiority of Relvar Ellipta compared to Seretide (Advair) Accuhaler fluticasone propionate/salmeterol DPI were included in the new filing.

Read the GSK and Innoviva press release.