MISSISSAUGA, ON, July 10, 2013 /CNW/ - BREO™ ELLIPTA™ (fluticasone
furoate/vilanterol) has been approved in Canada 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, and to reduce exacerbations of COPD in patients with a
history of exacerbations.1
BREO™ ELLIPTA™ 100/25 mcg is a combination of the inhaled corticosteroid (ICS) fluticasone furoate
and the long-acting beta2-agonist (LABA) vilanterol, administered by the new ELLIPTA™ dry powder
inhaler (DPI). BREO™ ELLIPTA™ 100/25 mcg contains 100 micrograms of fluticasone furoate (FF) and 25
micrograms of vilanterol (VI) as trifenatate. BREO™ ELLIPTA™ has been
shown to reduce airflow obstruction in patients with COPD and to reduce
exacerbations of COPD, or lung attacks, in patients with a history of
Recent research has shown that a significant number of COPD patients
prefer a once-daily medication, relative to having a more frequent
dosing regimen of two or four times daily.2
"When a person is affected by COPD, it can be debilitating, and the
simple act of taking a breath can be challenging. With the approval of
BREO™ ELLIPTA™100/25 mcg, we can now offer COPD patients a once-daily
option," said Glenn Crater, Country Medical Director for
GlaxoSmithKline Inc. "Through research we've learned that when
treatment administration is simplified, patients are more likely to use
it regularly and ultimately that can help improve the management of
The data submitted in support of the use of BREO™ ELLIPTA™100/25 mcg in
the treatment of COPD included results from a comprehensive program of
non-clinical studies, 52 clinical pharmacology studies of 1,406
patients, and 11 clinical studies of 7,851 patients with COPD. Of
these, there were four primary COPD studies: two 6-month lung-function
studies and two 1-year exacerbation studies.1
"For over forty years, GlaxoSmithKline has been at the forefront of
delivering medicines to patients with respiratory diseases,"
commented Paul Lirette, President, GlaxoSmithKline Inc. "We are
committed to responding to patients' needs and are very pleased to be
expanding our respiratory portfolio with the introduction of BREO™
ELLIPTA™ 100/25 mcg once-daily for the treatment of COPD in Canada."
BREO™ ELLIPTA™ was developed by Glaxo Group Limited in collaboration
with Theravance, Inc.
"We are very pleased with the approval of BREO™ ELLIPTA™ as a once-daily
treatment for COPD in Canada," said Rick E. Winningham, Theravance's
Chief Executive Officer. "We believe that BREO™ ELLIPTA™ has the
potential to be an important new treatment option for doctors and
patients dealing with this debilitating disease."
Following its authorization for use in the treatment of COPD, it is
anticipated BREO™ ELLIPTA™ 100/25 mcg will be made available in Canada
by GlaxoSmithKline by the end of 2013.
Chronic obstructive pulmonary disease (COPD) refers to two lung
diseases, chronic bronchitis and emphysema, which are characterised by
the obstruction of airflow that interferes with normal breathing. More
than 770,000 Canadians have been diagnosed with this serious disease.3 COPD is the leading cause of hospitalizations in Canada.4 It is also the fourth leading cause of death in Canada5 and the world.6 It is estimated COPD costs the Canadian health care system between $646
million to $736 million per year.7
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.8 Most people who have COPD are at least 40 years old when symptoms
begin.9 COPD symptoms vary over time and among patients, but they can include
chronic cough, shortness of breath and an increase of phlegm.1 When symptoms get worse or a new, persistent symptom comes on, patients
experience an exacerbation or lung attack.11 As COPD worsens over time, exacerbations can become more frequent,
potentially lead to hospitalization, restricted mobility and can
increase the risk of death.12,13,14
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.15 The long-term and progressive nature of symptoms can reduce the
quality of life in people with COPD, including the ability to work,
socialize and remain active.16
About BREO™ ELLIPTA™
BREO™ ELLIPTA™ 100/25 mcg is a long-term once-daily, inhaled corticosteroid/long-acting
beta2 agonist (ICS/LABA) combination treatment approved for COPD in Canada.
BREO™ ELLIPTA™ contains 100 micrograms of fluticasone furoate (FF) and 25 micrograms of
vilanterol (VI) as trifenatate, administered by the new ELLIPTA™ dry
powder inhaler (DPI).
Canadian prescribing Information for BREO™ ELLIPTA™ 100/25 mcg,
including BOXED WARNING and Consumer Information will be available soon
at www.gsk.ca. Prior to the label being posted online, health care
providers may request a copy of the complete Product Monograph by
calling GSK's Medical Information department at 1-800-387-7374.
Important safety information
BREO™ ELLIPTA™ is contraindicated in patients who are hypersensitive to fluticasone
furoate, vilanterol, or any ingredient in the formulation or component
of the container; and patients with severe hypersensitivity to milk
BREO™ ELLIPTA™ is not indicated for use in children and therefore should
not be used in patients under 18 years of age. BREO™ ELLIPTA™ is also not indicated for the relief of acute bronchospasm in COPD.
Patients should be prescribed a rapid onset, short duration inhaled
bronchodilator to relieve acute symptoms.
ASTHMA-RELATED DEATH: Long-acting beta2-adrenergic agonist (LABA) increase the risk of asthma-related death.
Data from a large, placebo-controlled US study that compared the safety
of another long-acting beta2-adrenergic agonist (salmeterol) to placebo added to usual asthma
therapy, showed an increase in asthma-related deaths in patients
receiving salmeterol. This finding with salmeterol is considered a
class effect of LABA, including vilanterol, the active ingredient in
BREO™ ELLIPTA™ is only indicated for COPD. The safety and efficacy of
BREO™ ELLIPTA™ in patients with asthma have not been established. BREO™
ELLIPTA™ is not indicated for the treatment of asthma.
BREO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of
About GlaxoSmithKline Inc.
GlaxoSmithKline (GSK) is a leading research-based pharmaceutical company
with a challenging and inspiring mission: to improve the quality of
human life by enabling people to do more, feel better, and live longer.
This mission gives GSK the purpose to develop innovative medicines,
vaccines and healthcare solutions that help millions of people.
Discover more at GSK.ca.
Theravance is a biopharmaceutical company with a pipeline of internally
discovered product candidates and strategic collaborations with
pharmaceutical companies. Theravance is focused on the discovery,
development and commercialization of small molecule medicines across a
number of therapeutic areas including respiratory disease, bacterial
infections, and central nervous system (CNS)/pain. By leveraging its
proprietary insight of multivalency to drug discovery, Theravance is
pursuing a best-in-class strategy designed to discover superior
medicines in areas of significant unmet medical need. For more
information, please visit Theravance's web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
Cautionary statement regarding GSK forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement, are
subject to risks and uncertainties that may cause actual results to
differ materially from those projected. Factors that may affect GSK's
operations are described under 'Risk factors' in the Annual Report for
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regarding, among other things, statements relating to goals, plans,
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detail under the heading "Risk Factors" contained in Theravance's
Quarterly Report on Form 10-Q filed with the Securities and Exchange
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Theravance assumes no obligation to update its forward-looking
1 BREO™ ELLIPTA™ Product Monograph, GlaxoSmithKline Inc., July 2013
2 Price D, Lee AJ et al. Characteristics of patients preferring
once-daily controller therapy for asthma and COPD: a retrospective
cohort study. Primary Care Respiratory Journal. 2013;22 http://dx.doi.org/10.4104/pcrj.2013.00017
3 Public Health Agency of Canada. Fast Facts About Chronic Obstructive
Pulmonary Disease. Available at: http://www.phac-aspc.gc.ca/cd-mc/publications/copd-mpoc/ff-rr-2011-eng.php [Last accessed: June 20 2013]
4 Canadian Institute for Health Information. A Snapshot of Health Care in
Canada as Demonstrated by Top 10 List. P.6. Available at https://secure.cihi.ca/free_products/Top10ReportEN-Web.pdf [Last accessed: June 20, 2013]
5 Statistics Canada. Leading Cause of Death by Sex. Available at: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/hlth36a-eng.htm [Last accessed: June 20, 2013]
6 Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management and Prevention of COPD, Global
Initiative for Chronic Obstructive Lung Disease (GOLD) [online] 2013.
Available from: http://www.goldcopd.org/uploads/users/files/GOLD_Report_2013_Feb20.pdf [Last accessed: April 2013]
7 N. Mittmann et. Al. The cost of moderate and severe COPD exacerbations to the
Canadian healthcare system.
Available at http://www.resmedjournal.com/article/S0954-6111(07)00432-5/fulltext [Last accessed: June 20 2013]
8 Canadian Lung Association. What is COPD. Available at: http://www.lung.ca/diseases-maladies/copd-mpoc/what-quoi/index_e.php [Last accessed: June 20, 2013]
9 World Health Organization. Chronic respiratory diseases: Diagnosis of
COPD 2013. Available at: http://www.who.int/respiratory/copd/diagnosis/en/index.html [Last accessed: June 20, 2013]
10 Canadian Lung Association. COPD Signs & Symptoms. Available at http://www.lung.ca/diseases-maladies/copd-mpoc/signs-signes/index_e.php [Last accessed: June 20 2013]
11 Global Initiative for Chronic Obstructive Lung Disease (GOLD). Pocket
guide to COPD diagnosis, management and prevention
12 Soler-Cataluna, JJ, et al. (2005) Severe acute exacerbations and
mortality in patients with chronic obstructive pulmonary disease.
Thorax 60, 925-931.
13 Cote, CG, Dordelly, LJ, Celli, BR (2007) Impact of COPD exacerbations
patient-centered outcomes. Chest, 131(3); 696-704
15 Rennard S, Decramer M 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
16 Canadian Lung Association. The Human and Economic Burden of COPD. Pg 5.
Available at: http://www.lung.ca/cts-sct/pdf/COPDReport_E.pdf [Last accessed: June 21, 2013]
SOURCE: GlaxoSmithKline Inc.
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