GlaxoSmithKline and Theravance have announced that a 12-week double-blind, parallel group Phase 3 study of their fluticasone furoate (FF)/vilanterol (VI) DPI (Breo/Relvar Ellipta) in almost 1,000 patients with moderate to severe asthma met its primary endpoint. According to the companies, both the 100/25mcg FF/VI and 200/25mcg FF/VI showed statistically significant improvement in FEV1, with a greater improvement for the higher dose, and the incidence of serious adverse events was less than 1% in all treatment arms.
Breo Ellipta was approved for the treatment of COPD in the US in May 2013, but it is not currently approved by the FDA for the treatment of asthma. In Europe, Relvar Ellipta was approved for the treatment of both COPD and asthma under certain conditions last month.
GSK Head, Respiratory Therapy Area Unit, R&D Dave Allen commented, “We are pleased to see the results delivered by FF/VI in the treatment of asthma. We have undertaken a large and comprehensive clinical program providing data on the efficacy and safety profile for FF/VI in asthma. With these additional data we will consider our next steps in relation to an asthma filing in the US.”
Read the GSK/Theravance press release.
