Novartis Phase III study shows ACZ885 (canakinumab) reduces cardiovascular risk in people who survived a heart attack
(Thomson Reuters ONE) -
Novartis International AG /
Novartis Phase III study shows ACZ885 (canakinumab) reduces cardiovascular risk
in people who survived a heart attack
. Processed and transmitted by Nasdaq Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
* Phase III CANTOS study met the primary endpoint, a composite of heart
attack, stroke and cardiovascular death, showing that ACZ885 (canakinumab)
in combination with standard of care therapy reduces cardiovascular risk in
people with a prior heart attack and inflammatory atherosclerosis
* Despite current treatments about 40% of heart attack survivors remain at
increased risk of recurrent heart attack, stroke or cardiovascular death
because of high-risk inflammatory atherosclerosis[1]; 25% experience another
event within five years[2]
* Full results will be presented at an upcoming medical congress; Novartis
plans to initiate discussions with regulatory authorities
Basel, June 22, 2017 - Novartis today announced topline results from the global
Phase III CANTOS study investigating the efficacy, safety and tolerability of
ACZ885 (canakinumab) in combination with standard of care in people with a prior
heart attack and inflammatory atherosclerosis. With more than 10,000 patients
enrolled in the study over the last six years, CANTOS is one of the largest and
longest-running clinical trials in Novartis' history.
The CANTOS study met the primary endpoint, demonstrating that when used in
combination with standard of care ACZ885 reduces the risk of major adverse
cardiovascular events (MACE), a composite of cardiovascular death, non-fatal
myocardial infarction and non-fatal stroke, in patients with a prior heart
attack and inflammatory atherosclerosis. The full data from the study will be
submitted for presentation at a medical congress and for peer reviewed
publication later this year.
"Despite current treatment, about 25 percent of heart attack survivors will have
another cardiovascular event within five years, making the outcome of the CANTOS
study a promising new development for patients," said Vas Narasimhan, Global
Head, Drug Development and Chief Medical Officer, Novartis. "ACZ885 is the first
and only investigational agent which has shown that selectively targeting
inflammation reduces cardiovascular risk. Our priority now is to thoroughly
analyze these important data and discuss them with regulatory agencies."
Heart attack occurs in about 580,000 people every year in EU5 and 750,000 people
in the United States alone[3],[4]. In 2015 there were an estimated 7.29 million
heart attacks globally[5]. Despite standard treatment, people with a prior heart
attack live with a higher ongoing risk of having another event or dying, and it
has been shown that in about four in 10 people, this risk is directly related to
increased inflammation associated with atherosclerosis[1]. The recurrent MACE in
patients with inflammatory atherosclerosis are associated with increased
morbidity, mortality and reduced quality of life and currently represent a major
economic burden on patients and healthcare systems around the world.
About CANTOS
The Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS)
(NCT01327846) is a randomized, double-blind, placebo-controlled, event-driven
Phase III study designed to evaluate the efficacy, safety and tolerability of
quarterly subcutaneous injections of ACZ885 (also known as canakinumab) in
combination with standard of care in the prevention of recurrent cardiovascular
(CV) events among 10,061 people with a prior myocardial infarction (MI) and with
a high-sensitivity C-reactive protein (hsCRP) level of >=2mg/L. The study
evaluated three different doses of ACZ885 vs placebo. The primary endpoint of
the study was time to first occurrence of major adverse CV event (MACE), a
composite of CV death, non-fatal MI, and non-fatal stroke. Secondary endpoints
included time to first occurrence of the composite CV endpoint consisting of CV
death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina
requiring unplanned revascularization; time to new onset type 2 diabetes among
people with pre-diabetes at randomization; time to occurrence of non-fatal MI,
non-fatal stroke or all-cause mortality; and time to all-cause mortality. The
median follow-up time was 3.8 years. The study ran for approximately six years.
About heart attack and inflammatory atherosclerosis
Heart attack occurs in about 580,000 people every year in EU5 and 750,000 people
in the United States alone[3],[4]. In 2015 there were an estimated 7.29 million
heart attacks globally[5]. Despite standard treatment, patients who have had a
prior heart attack live with a higher ongoing risk of secondary major adverse
cardiovascular events (MACE), a composite of cardiovascular (CV) death, non-
fatal MI, and non-fatal stroke. It has been shown that in about four in 10
people, this risk is directly related to the increased inflammation associated
with inflammatory atherosclerosis as measured by a high-sensitivity C-reactive
protein (hsCRP) biomarker level of >= 2mg/L[1]. The recurrent MACE in people
with inflammatory atherosclerosis are associated with increased morbidity,
mortality and reduced quality of life and currently represent a major economic
burden on patients and healthcare systems around the world.
About ACZ885
ACZ885 (canakinumab) is a selective, high-affinity, fully human monoclonal
antibody that inhibits IL-1ß, a key cytokine in the inflammatory pathway known
to drive the continued progression of inflammatory atherosclerosis[6]-[10].
ACZ885 works by blocking the action of IL-1ß for a sustained period of time,
therefore inhibiting inflammation that is caused by its over-
production[11],[12]. ACZ885 is the first and only agent which has shown that
selectively targeting inflammation significantly reduces cardiovascular risk in
patients who have had a prior heart attack and have an increased cardiovascular
inflammatory burden.
About the Novartis cardiovascular portfolio
Entresto(®) (sacubitril/valsartan) is the first and only approved medicine of
its kind. Entresto has been given a Class I recommendation in United States and
European Union clinical guidelines for treatment of heart failure with reduced
ejection fraction (HFrEF). Approved indications may vary depending upon the
individual country. Its unique mode of action reduces the strain on the failing
heart by enhancing the protective neuro-hormonal systems (e.g. natriuretic
peptide system) and simultaneously inhibiting the harmful effects of the
overactive renin-angiotensin-aldosterone system (RAAS).
To better understand heart failure (HF), Novartis has established FortiHFy, the
largest global clinical program in HF across the pharmaceutical industry.
FortiHFy has more than 40 active or planned clinical studies designed to extend
understanding of HF as well as to generate an array of additional data on
symptom reduction, efficacy, quality of life benefits and real world evidence
with Entresto.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "investigational," "investigating," "will," "plans to," "later
this year," "promising," "may," "priority," "portfolio," "recommendation,"
"planned," or similar terms, or by express or implied discussions regarding
potential marketing approvals for ACZ885, potential new indications or labeling
for Entresto, or regarding potential future revenues from ACZ885 or Entresto.
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 ACZ885 will be submitted or approved for sale in
any market, or at any particular time. Neither can there be any guarantee that
Entresto 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 ACZ885 or Entresto will be commercially successful in the future.
In particular, management's expectations regarding ACZ885 and Entresto 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; 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 and reimbursement
pressures; 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,
cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has
leading positions globally in each of these areas. In 2016, the Group achieved
net sales of USD 48.5 billion, while R&D throughout the Group amounted to
approximately USD 9.0 billion. Novartis Group companies employ approximately
118,000 full-time-equivalent associates. Novartis products are sold in
approximately 155 countries around the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis
For Novartis multimedia content, please visit www.novartis.com/news/media-
library
For questions about the site or required registration, please contact
media.relations(at)novartis.com
References
[1] Ridker P. How Common Is Residual Inflammatory Risk? Circ Res.
2017;120:617-619
[2] Heart Disease and Stroke Statistics-2017 Update: A Report From the American
Heart Association. Circulation. 2017;135:e146-e603
[3] EU5 MI trend. Based on Eurostat discharge data. Novartis data on file.
[4] Mozaffarian D, et al. Heart Disease and Stroke Statistics - 2016 Update: A
Report From the American Heart Association. Circulation. 2017; 135(23):e1-324.
[5] Roth G, et al. Global, Regional, and National Burden of Cardiovascular
Diseases for 10 Causes, 1990 to 2015. JACC. Available online May 17, 2017.
[6] Fearon WF, Fearon DT. Inflammation and cardiovascular disease: role of the
interleukin-1 receptor antagonist. Circulation. 2008;117:2577-2579.
[7] Duewell P, et al. NLRP3 inflammasomes are required for atherogenesis and
activated by cholesterol crystals. Nature. 2010;464(7293):1357-61.
[8] Rajamaki K, et al. Cholesterol Crystals Activate the NLRP3 Inflammasome in
Human Macrophages: A Novel Link between Cholesterol Metabolism and Inflammation.
PLoS One. 2010; 5(7):e11765.
[9] Ridker PM, Luscher TF. Anti-inflammatory therapies for cardiovascular
disease. Eur Heart J. 2014; 35(27):1782-91.
[10] Ridker PM. From C-Reactive Protein to Interleukin-6 to Interleukin-1. Circ
Res. 2016; 118:145-156.
[11] Ridker PM, et al. Effects of Interleukin-1ß Inhibition with Canakinumab on
Hemoglobin A1c, C-Reactive Protein, Interleukin-6 and Fibrinogen. Circulation.
2012; 126(23):2739-48.
[12] Ridker PM, et al. Interleukin-1ß inhibition and the prevention of recurrent
cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory
Thrombosis Outcomes Study (CANTOS). Am Heart J. 2011; 162(4):597-605.
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Agnes Estes
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 324 1896 (direct)
+41 79 593 4202 (mobile) +41 79 644 1062 (mobile)
eric.althoff(at)novartis.com agnes.estes(at)novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Cory Twining +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2114967/804731.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 22.06.2017 - 07:15 Uhr
Sprache: Deutsch
News-ID 549239
Anzahl Zeichen: 14811
contact information:
Town:
Basel
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 280 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Novartis Phase III study shows ACZ885 (canakinumab) reduces cardiovascular risk in people who survived a heart attack"
steht unter der journalistisch-redaktionellen Verantwortung von
Novartis International AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
