Novartis once-daily QVA149 shows superior efficacy in reducing exacerbations, improving lung function and quality of life in COPD patients
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Novartis International AG /
Novartis once-daily QVA149 shows superior efficacy in reducing exacerbations,
improving lung function and quality of life in COPD patients
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* SPARK results published in Lancet Respiratory Medicine showed that dual
bronchodilator QVA149 significantly reduced the rate of moderate or severe
COPD exacerbations compared to glycopyrronium 50 mcg
* QVA149 significantly reduced the rate of all COPD exacerbations compared to
open-label tiotropium 18 mcg and glycopyrronium
* QVA149 also demonstrated significant improvements in lung function and
health-related quality of life
Basel, April 23, 2013 - Results from the 64-week SPARK study published today in
Lancet Respiratory Medicine showed that investigational once-daily dual
bronchodilator QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) was
more effective at reducing all chronic obstructive pulmonary disease (COPD)
exacerbations compared to glycopyrronium 50 mcg and open-label (OL) tiotropium
18 mcg[1] a treatment with established efficacy in preventing
exacerbations[2],[3],[4],[5]. This is the first study to evaluate the effect on
exacerbations of dual bronchodilation with a fixed-dose combination of a long-
acting beta(2)-agonist (LABA) and a long-acting muscarinic antagonist (LAMA),
versus single LAMA therapies.
"We are delighted that results from SPARK demonstrated that QVA149 reduced the
overall rate of exacerbations in patients with severe and very severe COPD. For
physicians and their patients, these findings offer hope of a new effective
treatment to prevent debilitating COPD exacerbations and improve health-related
quality of life," said Tim Wright, Global Head of Development at Novartis Pharma
AG.
SPARK was a 64-week, multi-center, double-blind, parallel-group, active
controlled study with the primary objective to show superiority of QVA149
(indacaterol maleate 110 mcg / glycopyrronium 50 mcg) versus glycopyrronium 50
mcg for the rate of moderate to severe COPD exacerbations in 2,224 patients with
severe to very severe COPD. The key secondary objective was to show superiority
of QVA149 compared with OL tiotropium 18 mcg with respect to the rate of
moderate or severe COPD exacerbations during the treatment period. Patients aged
/>=40 years with >=1 COPD exacerbation in the year before were randomized to
receive either once-daily QVA149, glycopyrronium or OL tiotropium 18 mcg[1].
The study met its primary endpoint demonstrating that QVA149 significantly
reduced the rate of moderate or severe COPD exacerbations by 12% versus
glycopyrronium (p=0.038). The rate of moderate or severe exacerbations was
numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18
mcg. The rate of all (mild, moderate, and severe) exacerbations was
significantly reduced by 15% with QVA149 compared to glycopyrronium (p=0.0012)
and by 14% compared with OL tiotropium 18 mcg (p=0.0017). All treatments had an
acceptable safety profile, and there was no meaningful difference between the
treatment groups in the incidence of adverse and serious adverse event
reporting[1]. Novartis has previously released the First Interpretable Results
(FIR) for SPARK.
SPARK also demonstrated that the dual bronchodilator effect of QVA149 resulted
in substantially improved lung function. During the 64-week study, results
showed that lung function, as measured by trough FEV(1 )was significantly higher
with QVA149 compared to glycopyrronium (p<0.0001) and OL tiotropium 18 mcg
(p<0.0001) at each assessment during the treatment period.
Additionally, QVA149 showed significant differences in health-related quality of
life during the study as demonstrated by lower St George's Respiratory
Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium (p<0.01), and
OL tiotropium 18 mcg (p<0.05). Percentages of patients achieving the minimum
clinically important (>=4 unit) improvement in SGRQ total scores were higher
with QVA149 compared to glycopyrronium (p=0.055) or OL tiotropium 18 mcg
(p=0.051), even up to Week 64[1].
The effective management of COPD exacerbations is very important to both
patients and physicians, as exacerbations can impose a significant burden of
morbidity, mortality, reduced quality of life and increased healthcare
costs[6],[7]. Frequent exacerbations are linked to an accelerated decline in
lung function[8],[9]and patients are also known to have a poorer quality of
life[10]. Admissions to hospital due to exacerbations are increasing[11] and
patients with more severe underlying disease account for around 70% of the
direct medical costs of COPD[12].
Novartis is committed to addressing the unmet medical needs of COPD patients and
improving their quality of life by providing innovative medicines and devices.
SPARK is one of 10 studies investigating QVA149 for the treatment of COPD in the
IGNITE Phase III clinical trial program, which involves more than 7,000 patients
across 42 countries.
About the Novartis COPD portfolio
Onbrez(®) Breezhaler(® )(indacaterol maleate) is a LABA that offers clinically
relevant 24-hour bronchodilation combined with a rapid onset of action within
five minutes at first dose, as demonstrated in the INERGIZE Phase III trial
program. Onbrez Breezhaler 150 mcg QD provided greater clinical benefit in terms
of reduced shortness of breath, lower use of rescue medication and improved
health status, compared with blinded tiotropium 18 mcg. Onbrez Breezhaleris
approved in more than 100 countries around the world. It was first launched in
the EU (150 mcg and 300 mcg once-daily doses) and has since received approvals
in markets worldwide including Japan (Onbrez(® )Inhalation Capsules 150 mcg
once-daily) and US (Arcapta(TM) Neohaler(TM )75 mcg once-daily).
Once-daily Seebri(®) Breezhaler(®) (glycopyrronium bromide) is a novel inhaled
LAMA (also referred to as a long-acting anticholinergic) so far approved in EU,
Japan, Canada, Australia and other countries as a maintenance bronchodilator
treatment to relieve symptoms in adult patients with COPD. Glycopyrronium was
exclusively licensed to Novartis in April 2005 by Vectura and its co-development
partner Sosei. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that
glycopyrronium 50 mcg delivered rapid and significant sustained improvements in
lung function (measured by mean FEV(1)) from the morning on Day 1 compared with
placebo and sustained this for 24 hours over 52 weeks, and significantly
improved exercise endurance versus placebo.
QVA149 is an investigational inhaled, once-daily, fixed-dose combination of
indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for
the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is
one of the largest international clinical trial programs in COPD comprising 10
studies in total* (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE,
BEACON, RADIATE, LANTERN) with more than 7,000 patients across 42 countries. The
first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE**,
ARISE**, BEACON) have already completed in 2012. The studies are designed to
investigate efficacy, safety and tolerability, lung function, exercise
endurance, exacerbations, shortness of breath and quality of life.
*Total refers to all 10 IGNITE studies.
**BLAZE & ARISE were not included within the Q4 2012 filings to the EU and
Japan.
Novartis continues development of respiratory products for delivery via the
Breezhaler(®) device. This is a single-dose dry powder inhaler (SDDPI), which
has low air flow resistance, making it suitable for patients with airflow
limitation[13]. The Breezhaler(®) device allows patients to hear, feel and see
that they have taken the full dose correctly[14].
About COPD
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. It affects an estimated 210 million people worldwide[15] and is
projected to be the third leading cause of death by 2020[16]. 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[17].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "hope," "committed," "being investigated," "projected,"
or similar expressions, or by express or implied discussions regarding potential
marketing approvals for QVA149 or regarding potential future revenues from
QVA149. You should not place undue reliance on these statements. Such forward-
looking statements reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties and other factors
that may cause actual results with QVA149 to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that QVA149 will be submitted or approved
for sale in any market. Nor can there be any guarantee that QVA149 will achieve
any particular levels of revenue in the future. In particular, management's
expectations regarding QVA149 could be affected by, among other things,
unexpected regulatory actions or delays or government regulation generally;
unexpected clinical trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data; competition in
general; government, industry and general public pricing pressures; unexpected
manufacturing issues; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; the impact that the
foregoing factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance sheet,
and other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
estimated or expected. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis 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 128,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References:
[1] Wedzicha JA, Decramer M, Ficker JH, 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/onlinefirst Accessed 23 April 2013
[2] Niewoehner DE, Rice K, Cote C, et al. Prevention of exacerbations of chronic
obstructive pulmonary disease with tiotropium, a once-daily inhaled
anticholinergic bronchodilator: a randomized trial. Ann Intern Med
2005; 143: 317-26.
[3] Wedzicha JA, Calverley PM, Seemungal TA, et al, for the INSPIRE
Investigators. The prevention of chronic obstructive pulmonary disease
exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J
Respir Crit Care Med 2008; 177: 19-26.
[4] Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for
the prevention of exacerbations of COPD. N Engl J Med 2011; 364: 1093-103.
[5] Tashkin DP, Celli B, Senn S, et al, for the UPLIFT Study Investigators. A 4-
year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med
2008; 359: 1543-54.
[6] Simoens S et al. Clinical and economic analysis of antimicrobial therapy of
chronic obstructive pulmonary disease exacerbations. Int J Clin Pract.
2007; 61: 200-206.
[7] Hurst J et al. Chronic obstructive pulmonary disease: the clinical
management of an acute exacerbation. Postgrad Med J. 2004; 80: 497-505.
[8] Kanner RE, Anthonisen NR, Connett JE; Lung Health Study Research Group.
Lower respiratory illnesses promote FEV(1) decline in current smokers but not
ex-smokers with mild chronic obstructive pulmonary disease: results from the
lung health study. Am J Respir Crit Care Med 2001; 164:358-64
[9] Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between
exacerbation frequency and lung function decline in chronic obstructive
pulmonary disease. Thorax 2002; 57:847-52.
[10] Seemungal TA, Donaldson GC, Paul EA, et al. Effect of exacerbation on
quality of life in patients with chronic obstructive pulmonary disease. Am J
Respir Crit Care Med 1998; 157: 1418-22.
[11] Lung and Asthma Information Agency. Trends in hospital admissions for lung
disease. Fact sheet 2001/4. London: St George's Hospital Medical School.
[12] Sullivan SD, Ramsey SD, Lee TA: The economic burden of COPD. Chest
2000;117(suppl 2):5S-9S.
[13] Pavkov et al. Characteristics of a capsule based dry powder inhaler for the
delivery of indacaterol. CMRO 2010; 26; 11:2527-2533.
doi:10.1185/03007995.2010.518916.
[14] SPC: EMA. 2012. Seebri Breezhaler EU Summary of Product Characteristics.
[Online] 17 October 2012. Last accessed 6 February 2013.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/h
uman/002430/WC500133769.pdf
[15] 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. Last accessed 18
April 2013.
[16] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive
Pulmonary Disease. Updated 2011. http://www.goldcopd.org/guidelines-global-
strategy-for-diagnosis-management.html. Last accessed 14 April 2013.
[17] 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.
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