FDA informs Novartis of extension to US regulatory review period for QAB149, a novel once-daily bronchodilator for treatment of COPD
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Novartis International AG /
FDA informs Novartis of extension to US regulatory review period for QAB149, a
novel once-daily bronchodilator for treatment of COPD
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* US Food and Drug Administration (FDA) extends review period for new drug
application (NDA) by three months to July 2011
* Additional time requested to complete review of the large amount of data
from comprehensive clinical trial program
Basel, March 23, 2011 - Novartis announced today that the US Food and Drug
Administration (FDA) has extended the regulatory review period for QAB149
(indacaterol) for the once-daily long-term maintenance bronchodilator treatment
of airflow obstruction in patients with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and/or emphysema.
The FDA asked for a three-month extension in order to complete its review of the
new drug application (NDA) for QAB149 by July 2011. In its notification, the FDA
said it needed more time to examine the data submitted by Novartis in support of
the application. The agency did not request additional data.
"This three-month extension reflects discussion at the advisory committee based
on the comprehensive clinical program resulting in a large amount of data to be
reviewed," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma
AG. "COPD is a life-threatening lung disease and a major cause of serious long-
term disability[1]. We remain committed to bringing new therapies to patients
who suffer from this condition."
Last month the FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) endorsed
the safety of both the 75 and 150 mcg doses and voted in favor of approving
QAB149 75 mcg in the US, after Novartis presented data showing that QAB149
significantly improved lung function compared to placebo, with improvements seen
five minutes after the first dose and lasting for 24 hours[2].
The efficacy of Arcapta Neohaler at 75 and 150 mcg was demonstrated in an
extensive clinical trial program in a total of 1,282 COPD patients in five key
Phase III trials lasting 12-26 weeks[2].
QAB149 is already approved at 150 and 300 mcg once-daily doses in more than 50
countries worldwide under the brand-name Onbrez(®) Breezhaler(®) for the
maintenance bronchodilator treatment of airflow obstruction in COPD patients[3].
Incremental efficacy benefits have been observed with indacaterol in escalating
doses from 75 mcg up to 300 mcg, with higher doses showing increasing benefit
for patients[4],[5].
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "extension," "to complete," "extended," "committed," or
similar expressions, or by express or implied discussions regarding potential
marketing approvals for QAB149, or the timing of any such approvals, or
regarding potential future revenues from QAB149. 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 QAB149
will be approved for sale in the US or in any additional market, or regarding
the timing of any such approvals. Nor can there be any guarantee that QAB149
will achieve any particular levels of revenue in the future. In particular,
management's expectations regarding QAB149 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; 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, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. 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 (including 16,700 Alcon
associates) and operate in more than 140 countries around the world. For more
information, please visithttp://www.novartis.com.
References
[1] 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.
[2] Novartis data on file. Indacaterol (QAB149) in Chronic Obstructive Pulmonary
Disease Briefing Document. February 1, 2011.
[3] European Medicines Agency (EMA): Onbrez(®) Breezhaler(®) (indacaterol).
Summary of product characteristics. 4 January 2011.
[4] Donohue JF, et al. Once-daily bronchodilators for chronic obstructive
pulmonary disease: Indacaterol versus tiotropium. Am J Respir Crit Care Med
2010; 182:155-162.
[5] Kornmann O, et al. Once-daily indacaterol vs twice-daily salmeterol for
COPD: a placebo-controlled comparison. Eur Respir J 2011; 37:273-79.
# # #
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investor.relations(at)novartis.com
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Datum: 23.03.2011 - 07:16 Uhr
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