TRELEGY ELLIPTA approved in Canada as the first single inhaler triple therapy for the treatment of appropriate patients with COPD

Mississauga, ON -- TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol), has been approved in Canada as the first and only inhaler product that combines three active molecules for the long-term, once daily, maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema in patients who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-adrenergic agonist.

TRELEGY ELLIPTA is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta dry powder inhaler.

TRELEGY ELLIPTA availability is expected this June.

Dr. Susie Barnes, VP and Country Medical Director for GSK in Canada, said “COPD is a progressive and debilitating lung disease that can worsen over time, and represents a significant burden to patients and healthcare systems. The addition of TRELEGY ELLIPTA to our portfolio of respiratory medicines is an important milestone for GSK, building on our long heritage in this area and our relentless drive to ensure the right treatment for the right patient.”

"We are delighted that the long-standing collaboration between Innoviva and GSK to develop respiratory medicines that meet patient needs has led to the approval of TRELEGY ELLIPTA in Canada. This is a significant milestone as healthcare professionals now have a single inhaler triple therapy option to consider for their patients with COPD,” said Dr. Theodore J. Witek Jr., Senior Vice President and Chief Scientific Officer of Innoviva, Inc.

About COPD

Chronic obstructive pulmonary disease (COPD) a progressive lung disease, which includes chronic bronchitis and emphysema, and is characterized by the obstruction of airflow that interferes with normal breathing. It is a common but serious lung disease thought to affect 384 million people worldwide and 772,200 Canadians over 35 years old.[1] COPD is the leading cause of hospitalizations in Canada[2] and the fourth leading cause of death in Canada.[3] It is estimated COPD costs the Canadian health care system between $646 million to $736 million per year.[4] 

For people living with COPD, the inability to breathe normally can consume their daily lives and make simple activities, like walking upstairs, an everyday struggle.

Long-term exposure to inhaled 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. COPD symptoms vary over time and among patients, but can include chronic cough, shortness of breath and an increase of mucus.[5] As COPD worsens over time, exacerbations can become more frequent, potentially leading to hospitalization, restricted mobility and can increase the risk of death.[6],[7]

COPD can have a significant impact on the lives of patients and their families. Patients begin to accept their condition as normal, often understating its severity and the ways it has an impact on their daily life.[8] The long-term and progressive nature of symptoms can reduce the quality of life in people with COPD.

About TRELEGY ELLIPTA

TRELEGY ELLIPTA is a long-term, once-daily, maintenance treatment for chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, in patients who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-adrenergic agonist. TRELEGY ELLIPTA is not indicated for relief of acute bronchospasm or the treatment of asthma.

TRELEGY ELLIPTA contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2-adrenergic agonist, in one single inhaler, the Ellipta. The strength of TRELEGY ELLIPTA approved in Canada is 100/62.5/25 mcg. Please consult the Product Monograph that will be posted at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

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 information please visit www.gsk.ca.

Innoviva – Innoviva is focused on bringing 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 TRELEGY ELLIPTA, 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 BREO ELLIPTA and ANORO ELLIPTA. 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

Trademarks are owned by or licensed to the GSK group of companies.

GSK Enquiries:

Corporate Communications

+1 905-819-3363

(Mississauga)

 

 

+1 450-680-4812

(Laval)

 

 


References

[1] Public Health Agency of Canada: Chronic Diseases Link here

[2] Canadian Institute for Health Information: A Snapshot of Health Care in Canada as demonstrated by Top 10 List. P.6. Available here.

[3] Statistics Canada. Leading Cause of Death by Sex. http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/hlth36a-eng.htm

[4] N. Mittmann et. Al. The cost of moderate and severe COPD exacerbations to the Canadian healthcare system. Available here.

[5] Canadian Lung Association. COPD Signs & Symptoms. Available here

[6] Soler-Cataluna, JJ, et al. (2005) Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax 60, 925-931.

[7] Cote, CG, Dordelly, LJ, Celli, BR (2007) Impact of COPD exacerbations on patient-centered outcomes. Chest, 131(3); 696-704

[8] Rennard S, Decramer Et al. Impact of COPD in North America and Europe in 2000: Subjects’ perspective of confronting COPD International Survey. European Respiratory Journal. 2002:20 799-805.