GlaxoSmithKline plc (GSK) and biopharmaceutical company Theravance, Inc. 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.”
Umeclidinium/vilanterol is only approved for use in the US and Canada. It is not approved anywhere else in the world.
Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma.
Advair Diskus 250/50 is the approved dose for treatment of COPD in the US. Advair Diskus 500/50 is not approved for use in COPD in the US.
Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the US alone are affected by COPD1.
Anoro Ellipta is the first once-daily anticholinergic/LABA combination product approved in the US for the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. Anoro contains 62.5 mcg umeclidinium, an anticholinergic, and 25 mcg vilanterol, a LABA, in a single inhaler, the Ellipta.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Theravance – is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies.