GSK says study shows Relvar (Breo) Ellipta non-inferior to Seretide (Advair) for well-controlled asthma

GlaxoSmithKline has announced that a lung function study to demonstrate non-inferiority for once-daily use of the Relvar (Breo) Ellipta fluticasone furoate/vilanterol DPI compared to twice-daily Seretide (Advair) fluticasone propionate/salmeterol DPI in patients with well-controlled asthma met its primary endpoint.

In 2013, Relvar Ellipta was approved by the EU for the treatment of asthma in patients whose disease is not adequately controlled by an ICS plus an as-needed SABA.

The endpoint for the study was baseline change in FEV1 at the end of the 24-week treatment period. The company said that it would submit data from the study to the EMA and present the data in upcoming publications.

GSK Senior VP and Global Head of Respiratory Franchise Eric Dube said, “At GSK we are constantly searching for ways in which we can help patients better manage their asthma. In this positive study we have demonstrated non-inferiority for once-daily Relvar versus twice-daily Seretide on lung function. This gives us confidence that for patients who struggle taking a twice-daily treatment regimen, there may be a once-daily treatment option available, providing greater physician choice to help patients.”

Innoviva CEO Mike Aguiar commented, “We believe the results of this study are important for patients and physicians. They provide additional evidence that patients with persistent asthma, who are currently treated with a twice-daily ICS/LABA, in this case Seretide, can experience a similar level of benefit in lung function when treated with Relvar Ellipta, which only needs to be taken once a day.”

Read the GSK and Innoviva press release.