Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations
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Novartis International AG /
Major study published in NEJM confirms Novartis' Ultibro® Breezhaler®
superiority over Seretide® in preventing COPD exacerbations
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* FLAME study showed consistent superiority of Ultibro(®) Breezhaler(®) over
Seretide(® )across exacerbation outcomes, lung function and health-related
quality of life in COPD patients
* Ultibro Breezhaler also significantly reduced the rate and prolonged the
time to the first moderate or severe exacerbation, compared to Seretide
* Results published in the New England Journal of Medicine are anticipated to
have important implications for the care of people living with COPD
The digital press release with multimedia content can be accessed here:
Basel, May 15 2016 - Novartis today announced the New England Journal of
Medicine publication of the head-to-head FLAME study comparing the efficacy of
once-daily Ultibro(®) Breezhaler(®) (indacaterol/glycopyrronium bromide) 110/50
mcg to twice-daily Seretide(®) (salmeterol/fluticasone [SFC]) 50/500 mcg in
reducing chronic obstructive pulmonary disease (COPD) exacerbations. In addition
to meeting the primary endpoint (non-inferiority), findings demonstrated the
superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid
(ICS)/LABA* combination on exacerbation outcomes[1]. The published FLAME results
are anticipated to impact the future management and treatment of COPD patients.
* a long-acting beta(2)-adrenergic agonist
Preventing exacerbations is one of the primary goals of long-term care for COPD
patients. These episodes have a detrimental effect on quality of life and
disease progression[2], contributing to further lung function decline[3],[4]
and, in severe cases, hospitalization[5] and even death[2].
"Reducing exacerbations is absolutely critical to improve outcomes and quality
of life for COPD patients," said Vasant Narasimhan, Global Head Drug Development
and Chief Medical Officer for Novartis. "The FLAME study has clearly shown
that Ultibro Breezhaler is superior to the current standard of care in reducing
exacerbations, marking a shift away from therapies containing steroids for the
optimal treatment of COPD patients."
The results of FLAME confirmed that Ultibro Breezhaler is superior to SFC in
reducing exacerbation outcomes regardless of a patient's disease severity and
eosinophil levels (a type of white blood cell)[1]. Significantly, compared to
SFC, Ultibro Breezhaler both reduced the rate of moderate or severe
exacerbations with a 17% risk reduction (rate ratio, 0.83), and prolonged the
time to the first of these episodes with a 22% risk reduction (hazard ratio,
0.78)(1). The safety profiles of the two treatments were consistent with their
known profiles. The incidence of pneumonia was higher with SFC than Ultibro
Breezhaler (3.2% vs 4.8%: a statistically significant difference)[1].
These data were also presented to the scientific community for the first time
today at the 2016 Annual Meeting of American Thoracic Society (ATS) in San
Francisco, USA.
About FLAME
FLAME was a randomized, double-blind, double-dummy, parallel-group, non-
inferiority, active-controlled 52-week study involving 3,362 COPD patients and
conducted at 356 sites across 43 countries[6].
Results confirmed that Ultibro Breezhaler 110/50 mcg met its primary endpoint
(non-inferiority) and furthermore demonstrated superiority to SFC 50/500 mcg on
the rate of all COPD exacerbations (mild/moderate/severe) over one year of
treatment in COPD patients with a history of at least one exacerbation in the
previous year. Against further secondary endpoints, Ultibro Breezhaler was also
superior compared to SFC in reducing or improving the following[1]:
* Rate and time to first moderate or severe COPD exacerbation
* Time to first COPD exacerbation (mild/moderate/severe)
* Time to first severe COPD exacerbation
* Lung function (trough FEV[1])
* Health-related quality of life (St. George's Respiratory Questionnaire)
FLAME is part of the IGNITE Phase III clinical trial program exploring Ultibro
Breezhaler for the treatment of COPD.
About Ultibro Breezhaler
Ultibro Breezhaler 110/50 mcg is a once-daily LABA(+)/LAMA(++) dual
bronchodilator approved in the European Union (EU) as a maintenance
bronchodilator treatment to relieve symptoms in adult patients with COPD[7].
Clinical trials have shown that it offers statistically significant improvements
in bronchodilation compared to treatments widely used as current standards of
care, including SFC 50/500 mcg[8],[9],[10] and open-label tiotropium (18 mcg).
Ultibro Breezhaler is currently approved for use in over 80 countries worldwide,
including countries within the EU and Latin America, Japan, Canada, Switzerland
and Australia.
(+) a long-acting beta(2)-adrenergic agonist
(++) a long-acting muscarinic antagonist
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.
The Novartis COPD portfolio includes Ultibro Breezhaler
(indacaterol/glycopyrronium bromide), Seebri(®) Breezhaler(® )(glycopyrronium
bromide) and Onbrez(®) Breezhaler(®)/Arcapta(TM )Neohaler(TM) (indacaterol),
which are all indicated as maintenance treatments for COPD patients.
Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by
Vectura and its co-development partner Sosei.
Novartis continues development of respiratory products for delivery via the low
resistance Breezhaler(®) inhalation device, which makes it suitable for patients
with different severities of airflow limitation[11]. The Breezhaler device
allows patients to hear, feel and see that they have taken the full dose
correctly[7],[11].
About COPD
Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million
people worldwide[12] and is the third leading cause of death[13]. It is
progressive (usually gets worse over time), and can be a life-threatening
disease[14],[15]. COPD makes it difficult to breathe, with symptoms that have a
destructive impact on patients' function (i.e. activity limitation, decreased
mobility) and quality of life[14],[15].
Exacerbations (disease flare-ups) are a sudden worsening of COPD symptoms that
can be "frightening" for patients, causing distress, anxiety and the
deterioration of quality of life[16]. COPD exacerbations are also associated
with significant healthcare resource burden and costs[17], particularly due to
the frequent need for hospitalization. Consequently, the prevention of
exacerbations is an important goal in COPD management to improve long-term
health status and conserve healthcare resources[18].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "anticipated," "exploring," "committed," "continues," "can,"
"goal," or similar terms, or by express or implied discussions regarding
potential new indications or labeling for Ultibro Breezhaler, or regarding
potential future revenues from Ultibro Breezhaler or any of the products in the
Novartis COPD portfolio. You should not place undue reliance on these
statements. Such forward-looking statements are based on the current beliefs and
expectations of management regarding future events, and are subject to
significant known and unknown risks and uncertainties. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that Ultibro Breezhaler
will be submitted or approved for any additional indications or labeling in any
market, or at any particular time. Nor can there be any guarantee that any of
the products in the Novartis COPD portfolio will receive additional regulatory
approvals or be commercially successful in the future. In particular,
management's expectations regarding Ultibro Breezhaler or any of the other
products in the Novartis COPD portfolio could be affected by, among other
things, the uncertainties inherent in research and development, including
unexpected clinical trial results and additional analysis of existing clinical
data; unexpected regulatory actions or delays or government regulation
generally; the company's ability to obtain or maintain proprietary intellectual
property protection; general economic and industry conditions; global trends
toward health care cost containment, including ongoing pricing pressures;
unexpected manufacturing or quality issues; unexpected safety issues, and other
risks and factors referred to in Novartis AG's current Form 20-F on file with
the US Securities and Exchange Commission. 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 and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol/Glycopyrronium Versus
Salmeterol/Fluticasone for COPD Exacerbations. New England Journal of Medicine. 2016.
Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 15 May 2016].
[2] Soler-Cataluña JJ, Martinez-Garcia MA, Sanchez PR, et al. Severe acute exacerbations
and mortality in patients with chronic obstructive pulmonary disease. Thorax.
2005;60:925-931.
[3] 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.
[4] Vestbo J, Edwards LD, Scanlon PD, et al. Changes in forced expiratory volume in 1
second over time in COPD. N Engl J Med. 2011;365:1184-92.
[5] Müllerova H, Maselli DJ, Locantore N, et al. Hospitalized exacerbations of COPD: risk
factors and outcomes in the ECLIPSE cohort. Chest. 2015;147:999-1007.
[6] Clinicaltrials.gov. QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study
(FLAME). NCT01782326. Available at:
https://clinicaltrials.gov/ct2/show/NCT01782326?term=NCT01782326&rank=1 [Accessed 10
March 2016].
[7] Ultibro Breezhaler EU Summary of Product Characteristics. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-
_Product_Information/human/002679/ WC500151255.pdf [Accessed 10 March 2016].
[8] 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 -10:45].
[9] Vogelmeier C, et al. Once-daily QVA149 provides clinically meaningful improvements in
lung function and clinical outcomes. [ERS 2013 abstract 851178; Session 82; Date:
September 8, 2013 Time: 12:50-14:40].
[10] 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 2013 abstract 851388; Session 346; Date: September 10, 2013
Time: 8:30-10:30].
[11] Pavkov R, Mueller S, Fiebich K, et al. Characteristics of a capsule based dry powder
inhaler for the delivery of indacaterol. CMRO. 2010;26; 11:2527-2533.
[12] Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting.
Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf [Accessed 10
March 2016].
[13] World Health Organization: The top 10 causes of death fact sheet N(o) 310. Available
at: http://www.who.int/mediacentre/factsheets/fs310/en/ [Accessed 10 March 2016].
[14] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the
diagnosis, management, and prevention of chronic obstructive pulmonary disease.
Updated 2016. Available at:
http://www.goldcopd.org/uploads/users/files/WatermarkedGlobal%20Strategy%202016(1).pdf
[Accessed 10 March 2016].
[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_Manual/en/ [Accessed 10 March
2016].
[16] Adams R, Chavannes N, Jones K, et al. Exacerbations of chronic obstructive pulmonary
disease-a patients' perspective. Prim Care Respir J. 2006;15:2:102-109.
[17] Toy EL, Gallagher K, Stanley E, et al. The economic impact of exacerbations of chronic
obstructive pulmonary disease and exacerbation definition: a review. COPD.
2010;7:214-28.
[18] Anzueto A. Impact of exacerbations on COPD. European Respiratory Review.
2010;19:116:113-118.
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