According to GlaxoSmithKline and Theravance, the two companies have now completed all studies for the Relovair fluticasone furoate (FF)/vilanterol (VI) DPI for both COPD and asthma, and they plan to move forward now with regulatory submissions. GSK had previously announced that it would submit marketing applications for Relovair despite the fact that the FF/VI combination failed to produce statistically significant improvements in portions of several studies.
The company also announced new data from two studies, one of Relovair in patients with COPD and one of FF and fluticasone proprionate in patients with asthma. In the first study, which compared Relovair with Advair, Relovair “demonstrated numerical improvements but not statistical superiority over FP/SAL on the predefined primary endpoint of 0-24 hour weighted mean FEV1 (p=0.267).” In the asthma study, FF produced a statistically significant improvement in lung function compared to placebo after 24 weeks of treatment, meeting the primary endpoint. FP also met the primary endpoint.
GSK says that it will submit applications for FF/VI for the treatment of COPD in both the US and Europe around the middle of 2012. For asthma, the company says, it plans to submit an application in Europe at about the same time; in the US, it says it “will continue discussions with the FDA on the regulatory requirements for a US asthma indication.” Relovair is not currently approved in any country.
Read the GSK and Theravance press release.
