GlaxoSmithKline and Theravance have announced the completion of Phase 3 studies of their Relovair fluticasone furoate/vilanterol DPI for COPD. One Phase 3 study for the treatment of asthma remains to be completed. Despite the fact that the studies failed to produce statistically significant improvements in a number of measures, GSK says that it will submit applications for Relovair as a treatment for COPD to regulators in the US and Europe in mid-2012 and will submit an application for Relovair to treat asthma in Europe at about the same time.
GSK SVP Respiratory Portfolio Optimization Leader Darrell Baker commented, “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,” and Theravance CEO Rick Winningham added, “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.”
While one exacerbation study in the COPD program produced statistically significant reduction in exacerbations at all doses of Relovair, another study failed to show a statistically significant reduction at the highest dose. The exacerbation studies also failed to show statistically significant improvements in lung function compared to vilanterol alone in all doses, and GSK says that it is “investigating reports of fatal pneumonia on FF/VI primarily at the 200/25mcg dose.” According to the companies, they “believe that it is appropriate to request that regulatory authorities review the totality of the exacerbation data, including the effects seen across both studies for the 100/25mcg dose.”
Although a lung function profile study showed that the fluticasone/vilanterol combination resulted in statistically significant improvement in weighted mean FEV1 versus placebo at all doses, another study failed to show the superiority of the Relovair 100/25mcg once daily dose compared to Seretide fluticasone proprionate/salmeterol. Nevertheless, GSK plans to file applications at that dose this year.
In the asthma program, the FF/VI combination produced statistically significant reductions in exacerbations and improvement in lung function compared to fluticasone furoate alone in some, but not all studies. FF/VI did not show superiority to FP/SAL. Interpretation of one study comparing vilanterol to salmeterol was complicated when salmeterol, the active control, unexpectedly failed to demonstrate any statistically significant improvement in lung function compared to placebo. The remaining study, comparing fluticasone furoate to fluticasone proprionate and placebo should be completed by mid-2012.
Read the GSK/Theravance press release.
