Novartis commends publication of major report which recommends broad use of dual bronchodilators to treat COPD
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Novartis International AG /
Novartis commends publication of major report which recommends broad use of dual
bronchodilators to treat COPD
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The issuer is solely responsible for the content of this announcement.
* 2017 GOLD report recommends the first-line use of dual bronchodilators, such
as Ultibro(®) Breezhaler(®), in the treatment of the majority of symptomatic
COPD patients
* Bronchodilation regarded as the foundation treatment for COPD patients prior
to the use of inhaled steroid-containing therapies, as supported by
Novartis' FLAME study evidence
* Today's recommendations expected to translate to health care professionals
moving away from the historical reliance on inhaled corticosteroid
combinations for the treatment of COPD
Basel, November 21, 2016 - Novartis welcomes the publication of the Global
Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 report. For the
first time, GOLD has recommended the first-line use of dual bronchodilators,
such as Ultibro(®) Breezhaler(®) (indacaterol/glycopyrronium bromide) 110/50
mcg, in the treatment of the majority of symptomatic chronic obstructive
pulmonary disease (COPD) patients, regardless of their exacerbation risk[1].
The GOLD 2017 report is a tool to help health care professionals worldwide
implement effective COPD management programs. Significantly, the use of inhaled
steroid-containing combination therapies is now only recommended in a minority
of patients (those with a history of two or more exacerbations in the previous
year, or one hospitalization), following dual bronchodilator (LABA/LAMA*)
treatment[1].
"Today's publication of the new GOLD 2017 report is a major step in the fight to
help improve the diagnosis and management of COPD around the world," said Vasant
Narasimhan, Global Head Drug Development and Chief Medical Officer for Novartis.
"Reflecting the latest clinical evidence, the report not only supports
bronchodilation as a first treatment step for the majority of COPD patients, but
also recommends a more critical risk-based assessment of specific patient types
that may benefit from inhaled steroid-containing therapies. We are pleased that
the FLAME study helps underpin these important recommendations."
Today's new recommendations may translate to health care professionals moving
away from the historical reliance on inhaled corticosteroid (ICS)/LABA
combinations as first line therapy for the prevention of exacerbations[1]. The
GOLD 2017 report clearly identifies the elevated risk of adverse effects
(including pneumonia) when using these treatments and references evidence
showing no significant harm from withdrawing this medication in many patients
when used as part of a triple regimen[1].
Ultibro Breezhaler is currently the only steroid-free treatment to offer
prescribers clinically proven superiority over the most prescribed ICS/LABA
combination** in preventing COPD exacerbations[2]. The head-to-head FLAME
study[2] was considered significant enough to be included as a reference for the
first-line use of dual bronchodilators in symptomatic patients with high
exacerbation risk.
About GOLD
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) is an
independent organization that was launched in 1997. It collaborates with health
care professionals and public health officials worldwide to raise awareness of
COPD and improve disease prevention and treatment[3].
Through the development of evidence-based strategy documents for COPD
management, GOLD works to improve the lives of people with COPD in every corner
of the globe[1].
About Ultibro Breezhaler
Ultibro Breezhaler (indacaterol/glycopyrronium bromide) 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[4]. 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[5-7] and open-label tiotropium (18
mcg). Ultibro Breezhaler is currently approved for use in over 90 countries
worldwide, including countries within the EU and Latin America, Japan, Canada,
Switzerland and Australia.
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 and certain use and formulation intellectual property
were 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[8]. The Breezhaler device allows
patients to hear, feel and see that they have taken the full dose
correctly[4],[8].
About COPD
Chronic obstructive pulmonary disease (COPD) affects an estimated 210 million
people worldwide[9] and is the third leading cause of death[10]. It is
progressive (usually gets worse over time), and can be a life-threatening
disease[1],[9]. 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[1],[9].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "recommends," "recommendations," "expected," "may,"
"committed," "continues," or similar terms, or by express or implied discussions
regarding potential new indications or labeling for Ultibro Breezhaler or the
other products in the Novartis COPD Portfolio, or regarding potential future
revenues from Ultibro Breezhaler and the other 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 or any of the
other products in the Novartis COPD Portfolio 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 Ultibro Breezhaler or any of the other
products in the Novartis COPD Portfolio will be commercially successful in the
future. In particular, management's expectations regarding Ultibro Breezhaler
and 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 safety, quality or manufacturing 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
approximately 180 countries around the world. For more information, please visit
http://www.novartis.com.
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Notes
* Long-acting beta2-adrenergic agonist/Long-acting muscarinic antagonist
** Seretide(®) Accuhaler(®) (salmeterol/fluticasone) 50 microgram /500 microgram
/dose inhalation powder. Seretide and Accuhaler are registered trademarks of the
GlaxoSmithKline group of companies
References
[1] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
strategy for the diagnosis, management, and prevention of chronic obstructive
pulmonary disease. Updated 2017. Available at: http://goldcopd.org/ [Accessed
16 November 2016].
[2] Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus
Salmeterol-Fluticasone for COPD. New England Journal of Medicine. 2016.
Available at: www.nejm.org/doi/full/10.1056/NEJMoa1516385 [Accessed 16 November
2016].
[3] GOLD. About Us. Available at: http://goldcopd.org/about-us/ [Accessed 16
November 2016].
[4] 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 16 November 2016].
[5] 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].
[6] 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].
[7] 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].
[8] 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.
[9] 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 16 November
2016].
[10] 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 16
November 2016].
# # #
Novartis Media Relations
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E-mail: media.relations(at)novartis.com
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Novartis Global Media Relations Novartis Pharma Communications
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Media Release (PDF):
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 21.11.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 508199
Anzahl Zeichen: 14411
contact information:
Town:
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Kategorie:
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