DORVAL, QC, Sept. 9, 2013 /CNW/ - Novartis announced new analyses of
data for investigational QVA149 (indacaterol 85 mcg/glycopyrronium 43
mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per
capsule), which showed clinically significant improvements in lung
function, shortness of breath and health-related quality of life for
chronic obstructive pulmonary disease (COPD) patients versus those
comparators evaluated in the study1,2.These data were part of 39 respiratory abstracts presented at the
European Respiratory Society (ERS) Annual Congress in Barcelona, Spain.
First results from a pooled analysis of 4,891 COPD patients in the
IGNITE clinical trial program (SHINE, ILLUMINATE and SPARK studies)
showed that investigational QVA149 provided rapid and sustained
improvements in lung function, and significantly reduced shortness of
breath, evaluated against comparator treatments widely used as current
standards of care evaluated in the study1,2. These improvements were maintained throughout the duration of the
"These new trial results for investigational QVA149 are good news for my
COPD patients who struggle each day with a disease that causes
disabling breathlessness as they attempt simple everyday tasks," says
Dr. Kenneth Chapman, Director, Asthma & Airway Centre of the University
Health Network. "A new treatment option improving lung function and
relieving breathlessness around the clock with just one inhalation will
be a welcome advance."
"COPD is known to affect an estimated 210 million people worldwide3 and is projected to be the third leading cause of death by 20204.Many patients find COPD symptoms really tough to cope with - even if
they're already taking treatment," said Tim Wright, Global Head of
Development, Novartis. "Novartis is pleased that these new analyses
further support the efficacy of dual therapy, which has the potential
to make a real difference to peoples' lives."
Currently being assessed in a clinical trial program involving over
10,000 patients5-15, investigational QVA149 is a fixed-dose combination (FDC) of two
bronchodilators, ONBREZ* BREEZHALER* (indacaterol maleate), a
long-acting beta2-adrenergic agonist (LABA) and SEEBRI* BREEZHALER* (glycopyrronium
bromide), a long-acting anticholinergic (LAAC). Both are currently used
by healthcare professionals as individual therapies to treat COPD.
About the IGNITE clinical trial program
In the Phase III IGNITE clinical trial program, investigational QVA149
is being investigated for the treatment of COPD patients as an inhaled
FDC of indacaterol maleate and glycopyrronium bromide. IGNITE is one of
the largest international clinical trial programs in COPD comprising 11
studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE,
ARISE, BEACON, RADIATE, LANTERN, FLAME) with more than 10,000* patients
across 52 countries5-17. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK,
BLAZE, ARISE, BEACON) completed in 2012. The studies are designed to
investigate the efficacy, safety and tolerability, lung function,
exercise endurance, exacerbations, shortness of breath and quality of
life in patients treated with investigational QVA149.
Results from the Phase III IGNITE trials5-15 demonstrated statistically significant improvements in bronchodilation
with investigational QVA149 versus comparator treatments widely used as
current standards of care18. Data showed that investigational QVA149 significantly improved
bronchodilation providing a rapid onset within five minutes, and
sustained bronchodilation during a 24-hour period which was maintained
for up to 26 weeks19. In the IGNITE Phase III trial program, investigational QVA149 also
showed symptomatic improvements versus placebo in COPD patients5,6,8,18. These symptomatic improvements included shortness of breath, exercise
tolerance, rescue medication use and health-related quality of life5,6,8,18.
In clinical studies, investigational QVA149 demonstrated an acceptable
safety profile with no meaningful differences between the treatment
groups in the incidence of adverse and serious adverse events5,6,7,8,19.
*Total refers to all 11 IGNITE studies.
About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD
patients and improving their quality of life by providing innovative
medicines and devices.
Available in Canada, ONBREZ* BREEZHALER* (indacaterol maleate) 75 mcg is
a long-acting 2-agonist (LABA) indicated for long-term maintenance bronchodilator
treatment of airflow obstruction in patients with COPD, including
chronic bronchitis and emphysema. Also approved for use in Canada,
once-daily SEEBRI* BREEZHALER* (glycopyrronium bromide) is a novel
inhaled long-acting anticholinergic (LAAC; also referred to as a
long-acting muscarinic antagonist) indicated as a maintenance
bronchodilator treatment to relieve symptoms in adult patients with
COPD is often considered to be a disease of later years, but estimates
suggest that 50% of those with COPD are now less than 65 years old,
resulting in increases in absenteeism, premature retirement and
reductions in workforce participation22.
In Canada, 2009-2010 estimates show that 4% of Canadians aged 35 and
older are affected. Cigarette smoking is the principal cause,
accounting for 80% of COPD deaths23.
About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. In 2012, the
company invested close to $100 million in research and development in
Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada. For further information, please consult www.novartis.ca.
*SEEBRI, ONBREZ and BREEZHALER are registered trademark.
Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung
function and clinical outcomes. [ERS abstract 851178; Session 82; Date:
September 8, 2013 Time: 12:50-14:40].
Banerji D et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and
health status and reduces symptoms and rescue medication use in
patients with COPD: the IGNITE trials. [ERS abstract 851388; Session
346; Date: September 10 2013 Time: 8:30-10:30].
Global Alliance Against Chronic Respiratory Diseases (GARD). Global
surveillance, prevention and control of chronic respiratory diseases: a
comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf. [Accessed 3 September 2013].
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic
Obstructive Pulmonary Disease. Updated 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. [Accessed 3 September 2013].
Wedzicha JA et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with
the Dual Bronchodilator QVA149 Compared with Glycopyrronium and
Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respir Med 2013 http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70052-3/abstract [Accessed 3 September 2013].
Beeh et al. QVA149 once daily improves exercise tolerance and lung function in
patients with COPD: the BRIGHT study. [BTS Winter Meeting 2012, Poster
presentation P191; Date: 6 December; Time: 16:00-17:30].
Vogelmeier C et al. Efficacy and safety of once-daily QVA149 compared with twice-daily
salmeterol/fluticasone in patients with COPD (ILLUMINATE): a
randomised, double-blind, parallel group study. Lancet Respiratory Medicine. 2013;1(1): 51-60.
Bateman ED et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy:
the SHINE study. European Respiratory Journal http://erj.ersjournals.com/content/early/2013/05/30/09031936.00200212.full.pdf. [Accessed 3 September 2013].
Dahl et al. 2012. QVA administered once daily provides significant improvements in
lung function over 1 year in patients with COPD: The ENLIGHTEN study.
Volume abstract 853405.
Mahler D et al. Superior lung function with once-daily QVA149 translates into
improvements in patient reported breathlessness compared with placebo
and tiotropium in COPD patients: the BLAZE study. [ATS abstract 45308;
Session C20; Date: May 21, 2013 Time: 8:15-10:45].
ClinicalTrials.gov, n.d. Long Term Safety and Tolerability of QVA149
Versus Tiotropium in Japanese Patients With Chronic Obstructive
Pulmonary Disease (COPD) (ARISE). [Online] Available at: http://www.clinicaltrials.gov/ct2/show/NCT01285492?term=%28ARISE%29&rank=4 . [Accessed 3 September 2013].
ClinicalTrials.gov, n.d. Comparison of Safety and Efficacy of the
Combination Product QVA149A Against the Concurrent Administration of
the Individual Components, QAB149 and NVA237, in Patients With Chronic
Obstructive Pulmonary Disease (COPD) (BEACON). [Online] Available at: www.clinicaltrials.gov/ct2/show/NCT01529632?term=BEACON&rank=6. [Accessed 3 September 2013].
ClinicalTrials.gov, n.d. Comparison of Long-term Safety of the
Combination Product QVA149A Against Placebo and Standard of Care
Treatment in Chronic Obstructive Pulmonary Disease Patients With
Moderate to Severe Airflow Limitation (RADIATE). [Online] Available at:
www.clinicaltrials.gov/ct2/show/NCT01610037?term=GLISTEN&rank=1 .[Accessed 3 September 2013].
ClinicalTrials.gov, n.d. A 26-week Treatment Randomized, Double-blind,
Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and
Tolerability of QVA149 (Indacaterol / Glycopyrronium Bromide) Compared
to Fluticasone/Salmeterol in Patients With Moderate to Severe Chronic
Obstructive Pulmonary Disease. [Online]. Available at: www.clinicaltrials.gov/ct2/show/NCT01709903?id=01709903&rank=1. [Accessed 3 September 2013].
ClinicalTrial.gov, n.d. A 52-week Treatment, Multi-center, Randomized,
Double-blind, Double Dummy, Parallel-group, Active Controlled Study to
Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium
Bromide) With Salmeterol/Futicasone on the Rate of Exacerbations in
Subjects With Moderate to Very Severe COPD (FLAME). [Online] Available
at: http://clinicaltrials.gov/ct2/show/NCT01782326?term=COPD+novartis+52&rank=2 .[Accessed 3 September 2013].
FDA Access Data, n.d.Spiriva Medical Review Part 2. [Online] Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm. [Accessed 3 September 2013].
FDA Access Data, 2003.Advair Medical Review. [Online] Available at: www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKUS.pdf. [Accessed 3 September 2013].
Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung
function and clinical outcomes versus placebo, indacaterol,
glycopyrronium, tiotropium and salmeterol/fluticasone in patients with
COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15
Welte T et al. QVA149 once daily is safe and well tolerated in patients with COPD:
the SHINE study. [ATS abstract 41616; Session A43; Date: May 19, 2013,
EMA. 2012. aler EU Summary of Product Characteristics. [Online] 17
October 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002430/WC500133769.pdf. [Accessed 3 September 2013].
Joshi M et al. Symptom burden in chronic obstructive pulmonary disease and cancer. Obstructive, occupational and environmental diseases. 2012;18(2).
Fletcher MJ et al. COPD Uncovered: An International survey on the impact of chronic
obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011;11:612.
PHAC. Fast facts about Chronic Obstructive Pulmonary Disease (COPD)
2011. Available from: www.phac-aspc.gc.ca/cd-mc/publications/copd-mpoc/ff-rr-2011-eng.php. Accessed September 3, 2013.
SOURCE Novartis Pharmaceuticals Canada Inc.