GlaxoSmithKline (GSK) and Theravance, Inc. announced the completion of the phase III registration programme for the once-daily investigational medicine Relovair (fluticasone furoate “FF”/vilanterol “VI”) in patients with chronic obstructive pulmonary disease (COPD) and of all but one of the pivotal studies in patients with asthma.
For COPD, GSK intends to submit regulatory applications in the US and Europe in mid-2012. For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the FDA on the regulatory requirements for a US asthma indication.
Darrell Baker, SVP Respiratory Portfolio Optimisation Leader at GSK said: “We are pleased to have reached this milestone for Relovair, one of the important assets in our respiratory development portfolio. Having undertaken an initial assessment of these data we believe they support our plan to seek global approvals of this once-daily medicine for the treatment of patients with COPD and asthma.”
Rick E Winningham, chief executive officer of Theravance said: “We are very excited with the new data and GSK’s plan to submit regulatory applications for Relovair in the US and Europe this year. Relovair is one of our three respiratory programmes with GSK.”
The full results of these pivotal studies will be presented at future scientific meetings.
The development programmes for FF/Vl in COPD and asthma will continue as planned and include an outcomes study of 16,000 patients to prospectively evaluate the effect of the combination (FF/VI 100/25mcg) compared with placebo on survival in COPD patients with moderate disease and a history of, or at risk from, cardiovascular disease. In addition, GSK is in the process of setting up pre-registration real-world effectiveness studies to investigate the potential effects of FF/VI versus the standards of care in asthma and COPD. These studies are expected to commence shortly.
FF/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes LAMA/LABA (GSK573719/VI) and MABA (GSK961081), developed in collaboration with Theravance, as well as FLAP-inhibitor (GSK2190915), p-38 kinase inhibitor (losmapimod) and anti-IL5 MAb (mepolizumab). The phase III programme for LAMA/LABA is expected to complete in 2012.
Relovair is a trademark of the GlaxoSmithKline group of companies. The use of the brand name Relovair for FF/Vl is not approved by regulatory authorities around the world. Seretide and Advair are registered trademarks of GSK.