13.11.2020 16:00:16
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Press Release: New Novartis analyses for -2-
use the small interfering RNA (siRNA mechanism) of action to lower
low-density lipoprotein cholesterol (LDL-C), which could help improve
outcomes for patients with atherosclerotic cardiovascular disease
(ASCVD), a deadly form of cardiovascular disease(5,6,) (14). With two
doses a year and effective and sustained LDL-C reduction, inclisiran
works as a complement to statins. Inclisiran works differently from
other therapies by preventing the production of the target protein in
the liver, increasing hepatic uptake of LDL-C and clearing it from the
bloodstream(14). Inclisiran is dosed initially, again at 3 months, and
then once every 6 months. In three clinical trials, patients taking
inclisiran maintained LDL-C reduction throughout each 6-month dosing
interval(5,6). Administered in-office as a subcutaneous injection,
inclisiran integrates seamlessly into a patient's healthcare
routine(5,6).
No significant safety or tolerability concerns have been identified with
the long-term administration of inclisiran. In the Phase III trials,
inclisiran was well-tolerated with a safety profile shown to be
comparable to placebo(5,6). The most common adverse reactions reported
(>=3% of patients treated with inclisiran and occurring more frequently
than placebo) were injection site reaction, arthralgia, urinary tract
infection, diarrhea, bronchitis, pain in extremity and dyspnea. Adverse
events at the injection site were generally mild and none were severe or
persistent(5,6).
Novartis has obtained global rights to develop, manufacture and
commercialize inclisiran under a license and collaboration agreement
with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.
About Novartis in Cardiovascular-Renal-Metabolism
Bending the curve of life requires addressing some of society's biggest
public health concerns. Novartis has an established and expanding
presence in diseases covering the heart, kidney and metabolic system. In
addition to essential treatment Entresto(R) (sacubitril/valsartan),
Novartis has a growing pipeline of potentially first-in-class molecules
addressing cardiovascular, metabolic and renal diseases.
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform Act of
1995. Forward-looking statements can generally be identified by words
such as "potential," "can," "will," "plan," "may," "could," "would,"
"expect," "anticipate," "seek," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by express
or implied discussions regarding potential marketing approvals, new
indications or labeling for the investigational or approved products
described in this press release, or regarding potential future revenues
from such products. You should not place undue reliance on these
statements. Such forward-looking statements are based on our current
beliefs and expectations 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 the investigational or approved products described in
this press release will be submitted or approved for sale or for any
additional indications or labeling in any market, or at any particular
time. Nor can there be any guarantee that such products will be
commercially successful in the future. In particular, our expectations
regarding such products could be affected by, among other things, the
uncertainties inherent in research and development, including clinical
trial results and additional analysis of existing clinical data;
regulatory actions or delays or government regulation generally; global
trends toward health care cost containment, including government, payor
and general public pricing and reimbursement pressures and requirements
for increased pricing transparency; our ability to obtain or maintain
proprietary intellectual property protection; the particular prescribing
preferences of physicians and patients; general political, economic and
business conditions, including the effects of and efforts to mitigate
pandemic diseases such as COVID-19; safety, quality, data integrity or
manufacturing issues; potential or actual data security and data privacy
breaches, or disruptions of our information technology systems, 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 is reimagining medicine to improve and extend people's lives.
As a leading global medicines company, we use innovative science and
digital technologies to create transformative treatments in areas of
great medical need. In our quest to find new medicines, we consistently
rank among the world's top companies investing in research and
development. Novartis products reach nearly 800 million people globally
and we are finding innovative ways to expand access to our latest
treatments. About 110,000 people of more than 140 nationalities work at
Novartis around the world. Find out more at https://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at
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For Novartis multimedia content, please visit
https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact
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References
1. Wright RS, Ray KK, Raal FJ, et al. Efficacy and safety of
inclisiran according to sex: a pooled analysis of phase III studies
(ORION 9, 10 And 11). ePoster presentation (P2253) at: AHA Scientific
Sessions; November 2020.
2. Wright RS, Ray KK, Raal FJ, et al. Efficacy and safety of
inclisiran according to age: a pooled analysis of Phase III studies
(ORION 9, 10 And 11). ePoster presentation (P2250) at: AHA Scientific
Sessions; November 2020.
3. Ference B, Graham I, Tokgozoglu L, Catapano AL. Impact of lipids
on cardiovascular health: JACC health promotion series. J Am Coll
Cardiol. 2018;72:1141-1156.
4. Wong ND, Young D, Zhao Y, et al. Prevalence of the American
College of Cardiology/American Heart Association statin eligibility
groups, statin use, and low-density lipoprotein cholesterol control in
US adults using the National Health and Nutrition Examination Survey
2011-2012. J Clin Lipidol. 2016;10(5):1109-1118.
5. Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the treatment
of heterozygous familial hypercholesterolemia. N Engl J Med.
2020;382(16):1520-1530. doi:10.1056/NEJMoa1913805.
6. Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of
inclisiran in patients with elevated LDL cholesterol. N Engl J Med.
2020;382:1507-1519. doi:10.1056/NEJMoa1912387.
7. Clinicaltrials.gov. ORION -9, -10, -11. Accessed October 21st,
2020. https://www.clinicaltrials.gov/ct2/show/NCT03397121;
https://clinicaltrials.gov/ct2/show/NCT03399370;
https://www.clinicaltrials.gov/ct2/show/NCT03400800.
8. Mayo Clinic. Arteriosclerosis / atherosclerosis. Available from:
https://www.mayoclinic.org/diseases-conditions/arteriosclerosis-atherosclerosis/symptoms-causes/
[Last accessed: October 2020].
9. Goldstein J, Brown M. A century of cholesterol and coronaries:
from plaques to genes to statins. Cell. 2015;161(1):161--172.
10. World Health Organization. Cardiovascular diseases (CVDs).
Available from:
https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
[Last accessed: October 2020].
11. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke
Statistics--2012 update. Circulation. 2012;125(1):e2--e220.
12. Kim H, Kim S, Han S, et al. Prevalence and incidence of
atherosclerotic cardiovascular disease and its risk factors in Korea: a
nationwide population-based study. BMC Public Health. 2019;19(1):1112.
13. National Cholesterol Education Program (NCEP) Expert Panel on
Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults
(Adult Treatment Panel III). Third Report of the National Cholesterol
Education Program (NCEP) Expert Panel on Detection, Evaluation, and
Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel
III) final report. Circulation. 2002;106(25):3143--3421.
14. Stoekenbroek RM, Kallend D, Wijngaard PL, et al. Inclisiran for
the treatment of cardiovascular disease: the ORION clinical development
program. Future Cardiol. 2018;14(6):433--442.
# # #
Novartis Media Relations
E-mail: media.relations@novartis.com
Anja von Treskow Phil McNamara
Novartis External Communications Global Head, Cardio-Renal-Metabolism
+41 61 324 2279 (direct) Communications
E-mail: anja.von_treskow@novartis.com +41 79 510 8756 (mobile)
E-mail: phil.mcnamara@novartis.com
Eric Althoff
Novartis US External Communications
+1 646 438 4335
E-mail: eric.althoff@novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
Central North America
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
(END) Dow Jones Newswires
November 13, 2020 10:00 ET (15:00 GMT)
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Aktien in diesem Artikel
Novartis AG | 80,10 | -0,27% |
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Novartis AG (Spons. ADRS) | 104,00 | 1,46% |
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