DUAKLIR™ GENUAIR® now available in Canada for the treatment of chronic obstructive pulmonary disease

~Health Canada approval of DUAKLIR GENUAIR offers Canadians with COPD a safe and reliable twice-a-day option~¹

MISSISSAUGA, ON, Oct. 29, 2015 /CNW/ - AstraZeneca Canada announced today that DUAKLIR^™ GENUAIR^® (aclidinium bromide/formoterol fumarate dihydrate 400/12 μg) is now available in Canada for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.²

DUAKLIR offers a unique combination of a long-acting muscarinic antagonist (LAMA), aclidinium bromide and fast long acting beta₂-agonist (LABA), formoterol fumarate, administered through the GENUAIR device.^3,4,5

"Despite the treatment options available to patients living with COPD, there is still a significant unmet need when it comes to daily symptom control," says Dr. Ronald Grossman, respirologist, Credit Valley Hospital and professor of medicine at University of Toronto. "DUAKLIR GENUAIR provides patients with a safe, effective way to improve breathlessness over 24 hours. This improves lung function and gives them the confidence that their dosage is working consistently throughout the entire day."

Approximately 90 per cent of COPD patients experience symptoms such as breathlessness and coughing during at least one part of the day, and as many as 50 per cent experience symptoms around-the-clock.⁶

Research has shown that the GENUAIR device is preferred by patients when compared to other devices commonly used for COPD.^7,8,9,10 The inhaler is a pre-loaded, multi-dose dry powder inhaler (DPI) that combines positive feedback mechanisms with the DUAKLIR treatment, which relaxes the muscles of the airways, helping to keep them open, allowing the patient to breathe more easily.^11,12 By controlling the frequency of daily respiratory symptoms, DUAKLIR GENUAIR can help alleviate patient anxiety and stress related to dosing and symptom management.¹³ The device includes two physical mechanisms—a 'click' sound and a colour indicator change,¹⁴ which help reassure patients that their twice-a-day dosages are administered correctly.¹⁵

Today's announcement follows the Notice of Compliance issued by Health Canada on April 2, 2015, based on the efficacy and safety data from clinical studies. Results showed that DUAKLIR GENUAIR demonstrated statistically significant and sustained improvement in breathlessness.¹⁶ 

About COPD
COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 300 million people worldwide¹⁷ and is predicted to be the third leading cause of death by 2030.¹⁸ In Canada, COPD affects over 750,000 people,¹⁹ the fourth leading cause of death,²⁰ and poses a huge burden on health resources including hospitals, as well as the Canadian economy.²¹ Four per cent of Canadians aged 35 to 79 years old—approximately 1.5 million people—have reported a diagnosis by a health care professional for COPD, chronic bronchitis or emphysema.^22,23 While there is no cure for COPD, many treatments exist that can help ease the symptoms and slow disease progression over time, leading to a more active, full lifestyle. ^24,25

About the Health Canada Approval
The efficacy of DUAKLIR GENUAIR (aclidinium bromide/formoterol fumarate dihydrate) was established in two 6-month randomized, double-blind, placebo and active-controlled pivotal clinical trials (M/40464/30 and LAC-MD-31).The persistence of efficacy was assessed in a 6-month extension of study LAC-MD-31 (LAC-36) and in a further 12-month randomized controlled study (LAC-MD-32), where the long-term safety was also evaluated. These studies enrolled 3,986 patients aged ≥ 40 years who had a clinical diagnosis of stable moderate to severe COPD (with post-bronchodilator FEV1 of ≥ 30% to < 80% of predicted normal value) and a history of smoking of at least 10 pack-years. During these studies, patients were permitted to continue their stable treatment with inhaled corticosteroids, low doses of oral corticosteroids, oxygen therapy (if less than 15h/day) or methylxanthines and to use salbutamol as rescue medication.²⁶

DUAKLIR GENUAIR is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta₂-agonist (LABA). Adverse reactions to DUAKLIR GENUAIR are expected to be similar in nature to other beta₂-agonists and muscarinic antagonists. Adverse reactions that have been associated with muscarinic antagonists include cardiovascular effects (atrial arrhythmias and tachycardia), ocular disorders (e.g., blurred vision), urinary retention, gastrointestinal disorders (e.g., dry mouth). Adverse reactions that have been associated with beta₂-agonists include cardiovascular effects (tachycardia, arrhythmia, palpitations, myocardial ischaemia, hypertension or hypotension), hypokalemia, hyperglycemia, headache, nervousness, insomnia, muscle spasms and tremor.²⁷

About DUAKLIR GENUAIR
Aclidinium bromide/formoterol fumarate dihydrate 400/12 μg is an approved fixed-dose LAMA/LABA combination of two long-acting bronchodilators—aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-agonist (LABA). The fixed-dose combination was approved by the European Medicines Agency (EMA) for COPD in November 2014 and was subsequently launched in the UK (January 2015), Germany and the Netherlands (February 2015), Denmark (March 2015), and in Sweden (April 2015). DUAKLIR is available in 18 countries globally. It is now approved in Canada, as well as being approved and marketed as BRIMICA^® GENUAIR^® in Australia and Italy. Both aclidinium bromide and formoterol fumarate are separately approved for the maintenance treatment of COPD in Europe and the United States. Aclidinium bromide is also currently approved in 27 countries around the world, marketed under the name Tudorza^®/Eklira ^®, including Canada, Japan and Australia.

About GENUAIR
GENUAIR is a multi-dose, pre-loaded dry powder inhaler (DPI) with a unique combination of feedback mechanisms to reassure patients that the dose has been taken correctly. The inhaler's safety features ensure high levels of reliability.²⁸

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. AstraZeneca's Canadian headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

References
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¹ DUAKLIR GENUAIR Product Monograph. AstraZeneca Canada, April 2, 2015.
² Ibid.
³ Ibid.
⁴ Singh D, Chapman KR, Make BJ, et al. Effect of aclidinium Bromide/formoterol fumarate fixed-dose combination (FDC) on night time and early-morning symptoms in COPD. Eur Respir J. 2014;44 (Suppl 58):A2415.
⁵ Singh D, Jones P, Bateman E, et al. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomized study. BMC Pulm Med. 2014;14:178.
⁶ Miravitlles M, Worth H, Soler-Cataluña JJ, et al. Observational study to characterize 24-hour COPD symptoms and their relationship with patient reported outcomes: results from the ASSESS study. Respir Res. 2014;15(1):122.
⁷ Van der Palen J. et al. Preference, satisfaction and errors with two dry powder inhalers in patients with COPD. Expert Opin Drug Deliv 2013;10 (8):1023-1031.
⁸ Pascual S, et al. Preference, satisfaction and critical errors with GENUAIR and Breezhaler inhalers in patients with COPD: a randomised, cross-over, multicentre study. Primary Care Respiratory Medicine (2015) 25, 15018; doi:10.1038/npjpcrm.2015.18; Published online April 30 2015.
⁹ Ibid.
¹⁰ Beier J, et al. Efficacy and Safety of Aclidinium Bromide Compared with Placebo and Tiotropium in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: Results from a 6-week, Randomized, Controlled Phase IIIb Study. COPD. COPD. 2013. 10(4): 511–522. Published online June 22 2013. Last accessed September 2015.
¹¹ Gavaldà A, Miralpeix M, Ramos I, et al. Characterization of aclidinium bromide, a novel inhaled muscarinic antagonist, with long duration of action and a favorable pharmacological profile. J Pharmacol Exp Ther 2009;331:740-51.
¹² Health Canada Regulatory Decision Summary: DUAKLIR GENUAIR. Available at:http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds_sdr_duaklir_genuair_172711-eng.php. Last accessed October 2015.
¹³ Miravitlles M, Worth H, Soler-Cataluña JJ, et al. Observational study to characterize 24-hour COPD symptoms and their relationship with patient reported outcomes: results from the ASSESS study. Respir Res. 2014;15(1):122.
¹⁴ Health Canada Regulatory Decision Summary: DUAKLIR GENUAIR. Available at:http://www.hc-sc.gc.ca/dhp-mps/prodpharma/rds-sdr/drug-med/rds_sdr_duaklir_genuair_172711-eng.php. Last accessed October 2015.
¹⁵ Ibid.
¹⁶ Ibid.
¹⁷ Ekstrom MP, Bornefalk-Hermansson A et al. Safety of benzodiazepines and opioids in very severe respiratory disease: national prospective study. BMJ. 2014; 348: g445.
¹⁸ World Health Organisation. Burden of COPD. Available at: http://www.who.int/respiratory/copd/burden/en/. Last accessed September 2015.
¹⁹ The Lung Association. A New National Repertory Network Launches. Available at: http://www.lung.ca/news/latest-news-0/new-national-respiratory-network-launches. Last accessed September 2015.
²⁰ Proof Centre of Excellence. Backgrounder: Quick Facts About COPD. Available at: http://www.proofcentre.ca/wp-content/uploads/Quick-facts-about-COPD.pdf Last accessed September 2015.
²¹ Canadian Thoracic Society (2010). The human and economic burden of COPD: A leading cause of hospital admission in Canada. Available at: http://www.respiratoryguidelines.ca/sites/all/files/CTS_COPD_report.pdf. Last accessed September 2015.
²² Statistic Canada. Chronic obstructive pulmonary disease in Canadians, 2009 to 2011. Available at: http://www.statcan.gc.ca/pub/82-625-x/2012001/article/11709-eng.htm . Last accessed September 2015.
²³ Proof Centre of Excellence. Backgrounder: Quick Facts About COPD. Available at: http://www.proofcentre.ca/wp-content/uploads/Quick-facts-about-COPD.pdf Last accessed September 2015.
²⁴ Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Available at: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Apr2.pdf. Last accessed September 2015.
²⁵ National Heart, Lung and Blood Institute. How is COPD Treated? Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/copd/. Last accessed September 2015.
²⁶ DUAKLIR GENUAIR Product Monograph. AstraZeneca Canada, April 2, 2015.
²⁷ Ibid.
²⁸ Chrystyn H, Niederlander C. The GENUAIR® Inhaler: A Novel, Multidose Dry Powder Inhaler. Int J Clin Pract 2012; 66 (3): 309-317.

SOURCE AstraZeneca Canada Inc.

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