HEALTH CANADA APPROVES SYMBICORT® TURBUHALER®
FOR
CHRONIC OBSTRUCTIVE PULMONARY DISEASE – INCREASING PATIENTS’
QUALITY OF LIFE AND REDUCING EXACERBATIONS
~ Clinical studies also demonstrate that SYMBICORT TURBUHALER with
tiotropium, provides
rapid relief and significant improvements over challenging morning symptoms ~
Mississauga, ON [January 14, 2010] – AstraZeneca Canada Inc. announced
today that Health
Canada has approved SYMBICORT TURBUHALER (budesonide/formoterol) for the
maintenance treatment of chronic obstructive pulmonary disease (COPD) including
chronic
bronchitis and emphysema for as many as 750,000 Canadians who have the
condition.1 COPD is
a chronic lung disease that progressively damages the airways that go in and
out of the lungs.2
With an established history in respiratory disease, SYMBICORT TURBUHALER is
also
approved by Health Canada for the regular treatment of asthma.3
The use of SYMBICORT TURBUHALER in the treatment of patients with moderate to
severe
COPD is supported by two 12-month, randomized, double-blind,
placebo-controlled, parallel-
group, multicentre clinical studies comparing efficacy and safety of SYMBICORT
with placebo,
budesonide, and formoterol.3SYMBICORT TURBUHALER was shown to be
effective in
reducing exacerbations and providing early and sustained improvements in lung
function and
symptoms, together with improvements in health-related quality of life.4
In addition, data from the recent CLIMB study found that patients taking
SYMBICORT
TURBUHALER when used in combination with tiotropium, benefited significantly
with rapid
improved lung function and a greater ability to carry out morning activities
compared to those
treated with tiotropium alone.5The reported benefits were evident
after one week of treatment,
and continued to improve over the treatment period.5
“The Health Canada approval is exciting news for Canadians living with COPD,
especially as
SYMBICORT TURBUHALER has been seen to provide patients with an increased
quality of
life and a reduction in exacerbations,” says Dr. Meyer Balter, Director, Asthma
and COPD
Education Clinic, Mount Sinai Hospital. “In addition, clinical trials have
shown it to have a fast
onset of action and ease the morning symptoms of COPD, giving patients a better
start to their
day, enabling them to live a more active life.”
For patients with COPD, the morning is typically a time when symptoms are most
aggravated.6
The most common morning activities that have been reported as being
significantly affected by
severe COPD symptoms include walking up/down stairs, putting on shoes/socks,
and making the
bed, followed by dressing, and showering/bathing.6
About COPD in Canada
As many as 750,000 Canadians suffer from COPD,1 though 1.6 million
Canadians report
experiencing COPD symptoms without a diagnosis.2 Common symptoms of
COPD include
shortness of breath, wheezing, frequent and long-lasting lung infections (the
flu, pneumonia,
etc.), feeling tired2 and coughing with phlegm.7 The
leading cause of COPD is smoking cigarettes, which occurs in 80 to 90 per cent
of cases.2
About SYMBICORT TURBUHALER
SYMBICORT TURBUHALER is indicated for the maintenance treatment of moderate to
severe
COPD including chronic bronchitis and emphysema.3 For patients with
moderate to severe
COPD, the approved dosage of SYMBICORT TURBUHALER is 200/6 mcg two inhalations
twice daily.3 SYMBICORT TURBUHALER is also indicated for the regular
treatment of asthma
in patients 12 years of age and older.3 SYMBICORT TURBUHALER is a
combination of two
proven respiratory medications – budesonide, an inhaled corticosteroid (ICS) to
treat
inflammation, and formoterol, a rapid and long-acting beta2-agonist
(LABA) to address
bronchoconstriction. SYMBICORT TURBUHALER does not replace fast-acting inhalers
and
should not be initiated to treat acute symptoms of COPD or asthma.3 SYMBICORT
TURBUHALER is approved for use in the treatment of COPD in 96 countries
worldwide.
About AstraZeneca
AstraZeneca is a leading global pharmaceutical company with an extensive
product portfolio
spanning six major therapeutic areas: gastrointestinal, cardiovascular,
infection, neuroscience,
oncology, and respiratory. AstraZeneca's Canadian headquarters are located in
Mississauga,
Ontario, with a state-of-the-art drug discovery centre based in Montreal,
Quebec. For more
information, visit the company's website at www.astrazeneca.ca.
FOR MORE INFORMATION PLEASE CONTACT:
Marsha Knoll
Edelman
416-979-1120, ext. 329
Marsha.knoll@edelman.com
References:
1 Canadian Lung Association; Respiratory Guidelines
(2008).
http://www.lung.ca/cts-sct/pdf/Brochure-COPD.pdf Last
accessed August 19, 2009.
2 Canadian Lung Association.
http://www.lung.ca/diseases-maladies/copd-mpoc/what-quoi/index_e.php
Last accessed July 30, 2009.
3 SYMBICORT Product Monograph. July 29, 2009
4 Szafranski W, Cukier A, Ramirez A, et al. Efficacy and
safety of budesonide/formoterol in the management of chronic obstructive
pulmonary disease. European Respiratory Journal; 2003: 21: 74-81
5 Welte T, Miravitlles M, Hernandez P et al. Efficacy and
tolerability of Budesonide/formoterol added to tiotropium in COPD patients.
American Journal of Respiratory and Critical Care Medicine; 2009: 108:741-750.
6 Partridge MR, Karlsson N, Small IR. Patient insight
into the impact of chronic obstructive pulmonary disease in the morning:
an internet survey. Current Medical Research and Opinion 2009; 25:2043-8
7 Canadian Lung Association.
http://www.lung.ca/diseases-maladies/copd-mpoc/signs-signes/index_e.php
Last accessed July 30,2009.
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