GlaxoSmithKline and Innoviva Inc announced results from data presented at the American Thoracic Society (ATS) 2016 International Conference investigating the efficacy and safety of Anoro® Ellipta® (umeclidinium/vilanterol, ‘UMEC/VI’) in patients with moderate chronic obstructive pulmonary disease (COPD) who continued to have symptoms while on tiotropium monotherapy.
For patients in the study who were switched from tiotropium 18mcg to UMEC/VI 62.5/25mcg, a statistically significant improvement of 88mL (P<0.001; 95% CI 45, 131) was shown at week 12 for the primary efficacy endpoint of lung function (measured by trough FEV1), compared to patients who remained on tiotropium 18mcg for the duration of the study.
For the secondary efficacy endpoint of three hour post-dose FEV1,a statistically significant improvement in lung function of 73mL (P=0.004; 95% CI 24, 122) was also shown at week 12 for patients who were switched to UMEC/VI 62.5mcg, compared to patients who stayed on tiotropium 18mcg for the duration of the study.
Professor Neil Barnes, Global Respiratory Franchise Medical Head, GSK, said: “For COPD patients who remain symptomatic it is important that their lung function is optimised effectively. These efficacy data demonstrate the improvement in lung function that can be achieved in patients with moderate COPD when changing treatment from monotherapy with tiotropium 18mcg to dual bronchodilation with Anoro Ellipta.”
Furthermore, Dr. Ted Witek, Chief Scientific Officer of Innoviva, Inc. said: “This adds to the growing evidence base that shows that use of two mechanistic pathways can help symptomatic patients with COPD to improve their lung function.”
The most commonly reported adverse events for both UMEC/VI 62.5/25mcg and tiotropium 18mcg were nasopharyngitis (7% UMEC/VI 62.5/25mcg; 7% tiotropium 18mcg) and headache (6% UMEC/VI 62.5/25mcg; 7% tiotropium 18mcg). The overall incidence of on-treatment adverse events was 30% in the UMEC/VI 62.5/25mcg group and 31% in the tiotropium 18mcg group. The incidence of any on-treatment non-fatal serious adverse event was 2% in the UMEC/VI 62.5/25mcg arm and 2% in the tiotropium 18mcg arm. There was one fatal serious adverse event in the UMEC/VI group which was not related to study medication.
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.1 COPD is thought to affect 329 million people worldwide.2
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.3
About Anoro Ellipta
Anoro Ellipta is a combination long-acting muscarinic antagonist (LAMA) (also known as an anticholinergic) / long-acting beta2-adrenergic agonist (LABA).
In the US, Anoro Ellipta is indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Anoro Ellipta is not indicated for the relief of acute bronchospasm or for the treatment of asthma. The FDA-approved strength is umeclidinium/vilanterol 62.5/25mcg. Full US prescribing information, including BOXED WARNING and Medication Guide are available at: https://www.gsksource.com/gskprm/htdocs/documents/ANORO-ELLIPTA-PI-MG.PDF.
In Europe, Anoro is indicated as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. The approved strength in Europe is UMEC/VI 55mcg/22mcg (delivered dose, equivalent to 62.5mcg/25mcg pre-dispensed dose). For the EU Summary of Product Characteristics (SmPC), please visit: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002751/WC500168424.pdf
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. For further information please visit www.gsk.com.
Innoviva, Inc. – Innoviva, formerly known as Theravance, Inc., is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals. Innoviva’s portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, if approved and commercialized, VI monotherapy, as well. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance BioPharma, Inc. For more information, please visit Innoviva’s website at www.inva.com. RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.