Novartis receives FDA approval for Arcapta(TM) Neohaler(TM), a novel once-daily bronchodilator for chronic obstructive pulmonary disease
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Novartis International AG /
Novartis receives FDA approval for Arcapta(TM) Neohaler(TM), a novel once-daily
bronchodilator for chronic obstructive pulmonary disease
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* Arcapta is the only once-daily long-acting beta(2)-agonist (LABA) approved
in US for maintenance treatment of airflow obstruction in patients with COPD
* Clinical studies with Arcapta showed sustained improvement in lung function;
improvements were seen at 5-minutes after first dose[1]
* Arcapta is approved with data demonstrating improvements in health-related
quality of life
* COPD is a progressive and life-threatening lung disease that affects more
than 12 million Americans[2] and is a major cause of long-term disability[3]
Basel, July 1, 2011 - Novartis announced today that the US Food and Drug
Administration (FDA) has approved once-daily Arcapta(TM) Neohaler(TM)
(indacaterol inhalation powder) 75 mcg for the long-term maintenance
bronchodilator treatment of airflow obstruction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis and/or
emphysema[1]. Arcapta is not indicated for acute deteriorations of COPD or to
treat asthma.
The decision makes Arcapta, formerly known as QAB149, the first once-daily
therapy in the long-acting beta(2)-agonist (LABA) class to be approved in the US
for maintenance treatment of airflow obstruction in COPD patients.
"With millions of Americans known to be affected by COPD, the approval of
Arcapta is good news for patients," said John W. Walsh, president and co-founder
of the US-based COPD Foundation. "A new once-daily medicine is a welcome
addition to the treatment options for people suffering with this serious and
debilitating disease."
Arcapta 75 mcg was studied in a total of 641 COPD patients in two key Phase III
trials lasting 12 weeks. Results at week 12 showed that Arcapta significantly
improved lung function at 24 hours compared to placebo[1]. Lung function
improvements were seen five minutes after the first dose and consistently
maintained over 12 weeks. [1]. Arcapta also significantly reduced the need for
patients to use daily rescue medication[1]. Additionally, Arcapta improved
health-related quality of life compared to placebo, as measured with the St
George's Respiratory Questionnaire (SGRQ) [1]. The SGRQ is widely used in
clinical trials to measure symptoms, activities, and impact of COPD on daily
life as reported by patients[1].
The clinical trial program supporting US submission evaluated safety in 2,516
patients who received Arcapta for at least 12 weeks at doses of 75 mcg or
more[1], with results supporting the safety and tolerability profile of Arcapta.
The most common adverse reactions in 449 patients taking Arcapta 75 mcg (i.e.
those reported in more than 2% of patients and with higher incidence than
placebo) were cough, nasopharyngitis, headache, nausea and oropharyngeal pain.
"Novartis is focused on bringing innovative, safe and effective COPD medicines
to patients and physicians," said Trevor Mundel, MD, Global Head of Development
in the Pharmaceuticals Division of Novartis. "Indacaterol is the cornerstone of
our respiratory portfolio and this US approval represents a significant clinical
and regulatory milestone."
Indacaterol was first approved in November 2009 in the European Union under the
brand-name Onbrez(®) Breezhaler(®). It is now approved in more than 60 countries
for the treatment of COPD, and is available in more than 30 countries with
additional launches planned during 2011. The Arcapta US launch is planned for
the first quarter of 2012.
COPD is a progressive and life-threatening lung disease that makes it difficult
to breathe[4]. More than 12 million people in the US are affected, while another
estimated 12 million people are believed to have the disease but remain
undiagnosed[2]. COPD ranks as the third leading cause of death in the US[5], [6]
and is a major cause of serious long-term disability[3]. Worldwide, COPD is
estimated to affect a total of 210 million people[7].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "milestone," "planned," or similar expressions, or by
express or implied discussions regarding the development and marketing of
potential future respiratory product, regarding future launches of indacaterol,
or regarding potential future revenues from indacaterol. 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 to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that Novartis
will successfully develop or bring to market any additional respiratory
products. Nor can there be any guarantee that indacaterol will be launched in
any particular countries, or at any particular time. Neither can there be any
guarantee that indacaterol will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding indacaterol could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally, including unexpected reimbursement difficulties
or delays; competition in general; government, industry and general public
pricing pressures; unexpected clinical trial results, including unexpected new
clinical data and unexpected additional analysis of existing clinical data; 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 healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. Novartis is the only company with leading
positions in these areas. In 2010, the Group's continuing operations achieved
net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was invested in R&D
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 119,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
References
[1] Arcapta(TM) Neohaler(TM) PI, Draft, April 24, 2011
[2] National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2009 Chart
Book on Cardiovascular, Lung, and Blood Diseases. Bethesda, Maryland: U.S
Department of Health and Human Services, NIH, NHLBI. October 2009.
[3] Sin DD, Stafinski T, NG YC, Bell NR, Jacobs P. The impact of chronic
obstructive pulmonary disease on work loss in the United States. Am J Respir
Crit Care Med. 2002; 165: 704-707.
[4] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
strategy for the diagnosis, management, and prevention of chronic obstructive
pulmonary disease. Updated 2009.
[5] Minino AM, Xu J, Kochanek KD. Centers for Disease Control, Division of Vital
Statistics. Deaths: Preliminary Data for 2008. National Vital Statistics System.
December 2010; 59(2).
[6] Perez I. New CDC report puts COPD in #3 spot in mortality rates. COPD
Foundation. December
9, 2010.http://www.copdfoundation.org/PressRoom/tabid/170/language/en%E2%80%90US
/Default.aspx?News=114%00%00. Accessed January 21, 2011.
[7] 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 11
May 2011.
# # #
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investor.relations(at)novartis.com
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Datum: 01.07.2011 - 22:38 Uhr
Sprache: Deutsch
News-ID 56080
Anzahl Zeichen: 12149
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