Glaxo, Theravance Reveal Positive Results From 3 Late-stage Studies In COPD

(RTTNews) - GlaxoSmithKline Plc (GSK.L, GSK) and Theravance, Inc. (THRX) Friday announced positive results from three phase III studies.

Two studies compared the efficacy and safety of the combination anticholinergic / long-acting beta2-adrenergic agonist, Anoro Ellipta (umeclidinium/vilanterol, 'UMEC/VI') with inhaled corticosteroid / long-acting beta2-adrenergic agonist combination, Advair Diskus (fluticasone propionate/salmeterol 'FSC 250/50').

The third compared the efficacy and safety of Anoro Ellipta with Seretide Diskus 'FSC 500/50' in patients with chronic obstructive pulmonary disease or COPD and no history of moderate to severe COPD exacerbations in the last year.

In each of the studies UMEC/VI achieved a statistically significant improvement in lung function, measured as weighted mean forced expiratory volume in one second or wm FEV1 over 0-24 hours at the end of the 12 week study, compared to either dose of FSC.

Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said: "We are pleased to communicate these data comparing the effect of these treatments on the lung function of patients with COPD who do not have a history of exacerbations. These findings add to the existing body of evidence and our understanding of the efficacy and safety of UMEC/VI."

Umeclidinium/vilanterol is approved for use in the US and Canada. It is not approved anywhere else in the world.

The full results of these studies will be posted onto clinicaltrials.gov and presented at a future scientific meeting.