GSK and Theravance announce initial outcomes from pivotal Phase III studies for once-daily RelovairTM* in COPD and asthma
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today 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.
- (1888PressRelease) January 09, 2012 - 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 RelovairTM, 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 programs with GSK.”
The full results of these pivotal studies will be presented at future scientific meetings.
COPD Programme
The COPD programme included two replicate 52-week exacerbation studies each of which randomised approximately 1,620 patients. The studies were powered to compare each of 3 doses of FF/VI (200/25mcg, 100/25mcg and 50/25mcg) to VI 25mcg alone in a step-wise manner, starting at the highest dose. In both studies, all doses of FF/VI demonstrated reductions in the annual rate of moderate to severe exacerbations compared with VI alone. In the first study, the reductions were statistically significant at all doses (200/25mcg p
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