GlaxoSmithKline (GSK) and partner Theravance have completed two more phase III trials of Relovair, their combination therapy for chronic obstructive pulmonary disease (COPD) and asthma, and say they are now gearing up to file for approval later this year.
Relovair (fluticasone furoate and vilanterol) had been developed as a follow-up to GSK's big-selling Seretide/Advair (fluticasone propionate and salmeterol) product, which achieved sales of over £5bn ($7.9bn) last year but has started to slow down.
Patent protection for Advair starts to expire in Europe next year, so GSK is hoping to have Relovair approved and bringing in revenues as quickly as possible, although it argues that the Diskus inhaler used with the product will confer a competitive advantage even after generics enter the market.
Once again however, GSK and Theravance struggled to show that Relovair was unequivocally superior to Advair in COPD.
One phase III trial in this indication showing significantly better effects on respiratory function while another showed a numerical improvement but did not reach statistical significance. That pattern mirrored earlier phase III trial results.
Relovair still has the advantage over Advair of once-daily rather than twice-daily dosing, thanks to the inclusion of 'ultra' long-acting beta agonist (LABA) vilanterol.
GSK and Theravance also said they have completed a pivotal phase III trial in asthma, designed to compare both fluticasone furoate and fluticasone propionate to placebo.
GSK said Relovair would be filed for COPD in the US and Europe in the middle of the year and will also be submitted as a new treatment for asthma in Europe at the same time.
In the US however GSK said it will "continue discussions" with the FDA on its use in asthma, in light of more stringent regulatory requirements for new asthma therapies which have followed recent concerns about the safety of LABA drugs.