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news.GlaxoSmithKline (GSK) and Theravance have announced the completion of the phase III registration programme for the once-daily investigational medicine Relovair used to treat chronic obstructive pulmonary disease (COPD) and asthma.
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Relovair is a once-daily inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA) combination treatment, comprising fluticasone furoate and vilanterol (FF/VI), currently in development for the treatment of COPD and asthma.
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.
GSK intends to submit regulatory applications for COPD in the US and Europe in mid-2012, while for asthma, the company plans to submit an application in Europe in mid-2012 and will carry on discussions with the FDA on the regulatory requirements for a US asthma indication.
The investigational drug which is a trademark of the GlaxoSmithKline group is not currently approved anywhere in the world, the company said.