Novartis Pharmaceuticals Canada Inc. receives Health Canada approval for Ultibro(TM) Breezhaler®, a once-daily dual bronchodilator for COPD
-- Ultibro(TM) Breezhaler®1(QVA149), a long-term once-daily dual bronchodilator, received Health Canada approval on December 23rd 2013 for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema -- Pivotal Phase III IGNITE data showed QVA149 significantly improved lung function and patient-reported outcomes including breathlessness and rescue medication use, compared to current standards of care2,3,4
DORVAL, QC, Jan. 13, 2014 /CNW/ – Novartis Pharmaceuticals Canada Inc.
(Novartis) announced today that Health Canada has approved the use of
long-term once-daily dual bronchodilator Ultibro(TM) Breezhaler(® )(indacaterol 110 mcg / glycopyrronium 50 mcg) as a maintenance
bronchodilator treatment of airflow obstruction in patients with
chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and emphysema.
“The availability of ULTIBRO® BREEZHALER® is good news for my patients
with COPD who struggle with disabling breathlessness as they attempt
simple everyday tasks.” says Dr. Kenneth Chapman, Director, Asthma &
Airway Centre of the University Health Network, located in Toronto. “A
new treatment option that improves lung function and relieves
breathlessness around the clock following just one inhalation is a
Health Canada approved Ultibro(TM) Breezhaler(®) based on five studies from the IGNITE clinical program (SHINE(2), ILLUMINATE(3), SPARK(4), BRIGHT(5) and ENLIGHTEN(6) studies). These studies showed that QVA149 provided rapid and sustained
improvements in lung function, and significantly reduced shortness of
breath. These improvements were maintained throughout the duration of
the trials(13,14). The IGNITE clinical program is one of the largest international phase
III clinical trial programs in COPD, with 11 trials in total and more
than 10 000 patients involved.( 2-12)
Ultibro(TM) Breezhaler(®) is a fixed-dose combination (FDC) of two bronchodilators, Onbrez(®) Breezhaler(®15 )(indacaterol maleate), a long-acting beta(2)-adrenergic agonist (LABA) and Seebri(®) Breezhaler(®16 )(glycopyrronium bromide), a long-acting anticholinergic (LAAC). Both are
currently used by healthcare professionals as individual therapies to
treat COPD in Canada.
“COPD is known to affect an estimated 210 million people worldwide(17 )and is projected to be the third leading cause of death by 2020(18). Several patients find COPD symptoms really tough to cope with – even
if they’re already taking treatment,” said Dr. Riad Sherif, President
of Novartis. “With the approval of Ultibro(TM) Breezhaler(®), Novartis is pleased that Health Canada recognizes the efficacy of dual
therapy, which has the potential to make a real difference for those
About the IGNITE clinical trial program
In the Phase III IGNITE clinical trial program, Ultibro(TM) Breezhaler(®) (QVA149) was 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 countries(2-12,19,20). 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 QVA149.
Results from the Phase III IGNITE trials(2-12) demonstrated statistically significant improvements in bronchodilation
with Ultibro(TM) Breezhaler(®) versus placebo. Data showed that Ultibro(TM) Breezhaler(®) significantly improved bronchodilation providing a rapid onset and
sustained bronchodilation during a 24-hour period which was maintained
for up to 26 weeks(21). In the IGNITE Phase III trial program, Ultibro(TM) Breezhaler(®) also showed symptomatic improvements versus placebo in COPD patients(2,4,5,13). These symptomatic improvements included shortness of breath, exercise
tolerance, rescue medication use and health-related quality of life(2,4,5,13).
In clinical studies, Ultibro(TM) Breezhaler(®) demonstrated an acceptable safety profile with no meaningful
differences between the treatment groups in the incidence of adverse
and serious adverse events(2,3,4,5,21). The most common adverse drug reactions related to Ultibro(TM) Breezhaler(®) were cough and oropharyngeal pain(1).
*Total refers to all 11 IGNITE studies.
About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of patients
with respiratory diseases 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
Also approved for use in Canada, once-daily Seebri(®) Breezhaler(® )(glycopyrronium bromide) 50 mcg is a novel inhaled long-acting
anticholinergic (LAAC; also referred to as a long-acting muscarinic
antagonist) indicated as a maintenance bronchodilator treatment in
patients with COPD, including chronic bronchitis and emphysema(16).
COPD is a progressive life-threatening disease that makes it hard to
breathe, with symptoms that have a destructive impact on patients’
function and quality of life(18,22). It affects an estimated 210 million people worldwide(17 )and is projected to be the third leading cause of death by 2020(18).
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 participation(23).
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 deaths(24).
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.
Novartis Pharmaceuticals Canada Inc. is an affiliate of Novartis AG,
which provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools,
over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2012, the
Group achieved net sales of USD 56.7 billion, while R&D throughout the
Group amounted to approximately USD 9.3 billion (USD 9.1 billion
excluding impairment and amortization charges). Novartis Group
companies employ approximately 133,000 full-time equivalent associates
and operate in more than 140 countries around the world. For more
information, please visit www.novartis.com.
(TM)Ultibro is a trademark of Novartis Pharmaceuticals Canada Inc.
®Onbrez, Seebri and Breezhaler are registered trademarks of Novartis
Pharmaceuticals Canada Inc.
1. Ultibro(TM) Breezhaler® Product Monograph, Novartis Pharmaceuticals Inc. 2. Bateman ED et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. European Respiratory Journalhttp://erj.ersjournals.com/content/early/2013/05/30/09031936.00200212.full.pdf. [Accessed 3 September 2013]. 3. 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. 4. 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 Respiratory Medicine 2013;1(3): 199-209. 5. 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]. 6. 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. 7. 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]. 8. 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]. 9. 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]. 10. 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]. 11. 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]. 12. 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]. 13. 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]. 14. 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]. 15. Onbrez® Breezhaler® Product Monograph, Novartis Pharmaceuticals Inc 16. Seebri® Breezhaler® Product Monograph, Novartis Pharmaceuticals Inc 17. 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]. 18. 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]. 19. 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]. 20. 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]. 21. 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, 8:15-16.30]. 22. Joshi M et al. Symptom burden in chronic obstructive pulmonary disease and cancer. Obstructive, occupational and environmental diseases. 2012;18 (2). 23. 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. 24. 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.