GlaxoSmithKline and partner Theravance have been boosted by positive data from two Phase III studies for Relovair, which show that the inhaled combination drug is efficacious and safe in patients with chronic obstructive pulmonary disease.
Relovair (fluticasone/vilanterol) is a once-daily inhaled corticosteroid/long-acting beta-agonist combo. The two six-month studies randomised some 2,200 patients with moderate to severe COPD to receive Relovair, fluticasone alone, vilanterol alone or placebo. In both studies, new combination was associated with significant improvements in two measures of lung function, compared to placebo over 0-4 hours.
Statistically significant improvements were also observed for vilanterol alone, compared to placebo, but in a further analysis, Relovair demonstrated numerical improvements in one of the measures (trough FEV1) over vilanterol alone, although these results were not seen as significant.
GSK said the results, together with data from two ongoing 12-month exacerbation studies, will be included in regulatory submissions. Relovair is also in Phase III for asthma.
Relovair has been dubbed 'Super Advair' as it is the follow-up product to its biggest-selling drug Advair (salmeterol/fluticasone). Commenting on the news, Navid Malik, an analyst at Matrix Group, said "we believe that GSK is demonstrating the continued ability to deliver potential blockbusters from its pipeline, the results from both of these Phase III studies reinforce this view".