GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS®

Posted: 14 March 2014 | | No comments yet

GlaxoSmithKline plc and Theravance, Inc. announced positive results from three phase III studies…

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GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from three phase III studies. Two studies comparing 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’) and the third comparing the efficacy and safety of Anoro Ellipta with Seretide® Diskus® ‘FSC 500/50’ in patients with chronic obstructive pulmonary disease (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 (wm FEV1) over 0-24 hours at the end of the 12 week study (day 84), 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.”

Rick E Winningham, Chief Executive Officer of Theravance said: “We are pleased to announce the results from these positive studies, which provide physicians with further data regarding UMEC/VI as a treatment option for appropriate patients with COPD.”