Novartis' Entresto® given strong Class I recommendation in both US and EU heart failure guidelines, less than a year after regulatory approvals
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Novartis' Entresto® given strong Class I recommendation in both US and EU heart
failure guidelines, less than a year after regulatory approvals
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* US guidelines now recommend Entresto as standard of care for HFrEF as an
alternative to ACEs or ARBs; call for doctors to switch patients with mild
to moderate symptoms to Entresto[1]
* Updated guidelines from the European Society of Cardiology recommend
Entresto instead of an ACE or ARB in patients fitting the PARADIGM-HF
profile[2]
* Guidance underscores the benefits of Entresto for patients to significantly
reduce risk of death due to cardiovascular causes or heart failure
hospitalization
Basel, May 21, 2016 - Entresto(®) (sacubitril/valsartan) has been given a Class
I recommendation, the strongest endorsement, in updated clinical practice
guidelines simultaneously released by the American College of Cardiology (ACC),
the American Heart Association (AHA) and the Heart Failure Society of America
(HFSA) in the US, and the European Society of Cardiology in the EU.
In the US Entresto is now a standard therapy for heart failure with reduced
ejection fraction (HFrEF) as an alternative to an ACE inhibitor or an
angiotensin II receptor blocker, given together with a beta blocker and an
aldosterone antagonist. In addition, the guidelines call for doctors to switch
HFrEF patients with mild to moderate symptoms from ACEs or ARBs to Entresto.
"These strong, swift and broad recommendations by US cardiology organizations,
redefine the standard of care for how reduced ejection fraction heart failure is
treated," said Vas Narasimhan, Global Head of Development and Chief Medical
Officer for Novartis. "We know patients with heart failure suffer reduced
quality of life and remain at high risk of hospitalization or death, and these
new guidelines are a strong call to action to ensure patients receive the most
effective therapies."
In the EU, the ESC HF guidelines recommend doctors switch HFrEF patients meeting
the PARADIGM-HF criteria to Entresto from an ACE or ARB. Both guideline
committees considered evidence from PARADIGM-HF, the largest heart failure trial
ever, which showed Entresto significantly reduced deaths from cardiovascular
causes and heart failure hospitalizations in patients with HFrEF[3].
Heart failure is a debilitating and life-threatening condition, which impacts
over 60 million people worldwide[4]. It is the leading cause of hospitalization
in people over the age of 65[5],[6]. About half of people with heart failure
have HFrEF[7]. Reduced ejection fraction means the heart does not contract with
enough force, so less blood is pumped out[8]. Heart failure presents a major and
growing health-economic burden that currently costs the world economy $108
billion every year[5],[9].
Novartis has established the largest global clinical program in the heart
failure disease area across the pharma industry to date, FortiHFy, comprising
over 40 active or planned clinical studies designed to generate an array of
additional data on symptom reduction, efficacy, quality of life benefits and
real world evidence with Entresto, as well as to extend understanding of heart
failure.
About Entresto
Entresto is a twice-a-day medicine that reduces the strain on the failing heart.
It does this by enhancing the protective neurohormonal systems of the heart (NP
system) while simultaneously suppressing the harmful effects of the overactive
renin-angiotensin-aldosterone system (RAAS)[10]. Other heart failure medicines
only block the harmful effects of the overactive RAAS[11]. Entresto contains the
neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB)
valsartan[10].
In Europe, Entresto is indicated in adult patients for treatment of symptomatic
chronic heart failure with reduced ejection fraction. In the U.S. Entresto is
indicated for the treatment of heart failure (NYHA class II-IV) in patients with
systolic dysfunction. It has been shown to reduce the rate of cardiovascular
death and heart failure hospitalization compared to enalapril, and also to
reduce the rate of all-cause mortality compared to enalapril. Entresto is
usually administered in conjunction with other heart failure therapies, in place
of an ACE inhibitor or other angiotensin receptor blocker (ARB). Approved
indications may vary depending upon the individual country.
About PARADIGM-HF
PARADIGM-HF was a randomized, double-blind, phase III study evaluating the
efficacy and safety profile of Entresto versus enalapril (a widely studied ACE
inhibitor) in 8,442 patients with HFrEF. The baseline characteristics showed the
patients enrolled were typical HFrEF patients with NYHA Class II-IV heart
failure. PARADIGM-HF was specifically designed to see if LCZ696 could decrease
CV mortality by at least 15% vs. enalapril. Patients received LCZ696 or
enalapril in addition to current best treatment regimen. The primary endpoint
was a composite of time to first occurrence of either cardiovascular death or
heart failure hospitalization, and is the largest heart failure study ever done.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "recommendation," "guidelines," "recommend," "call for,"
"guidance," "call to action," "recommend," "growing," "planned," "designed to,"
or similar terms, or by express or implied discussions regarding potential new
indications or labeling for Entresto, or regarding potential future revenues
from 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 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 Entresto will be
commercially successful in the future. In particular, management's expectations
regarding Entresto 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 more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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# # #
References
[1] https://content.onlinejacc.org/article.aspx?articleid=2524644
[2] 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic
heart failure. European Heart Journal. doi:10.1093/eurheartj/ehw128
[3] McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in
Heart Failure, N Engl J Med 2014.
[4] Global Burden of Disease Study 2013 Collaborators. Global, regional, and
national incidence, prevalence, and years lived with disability for 301 acute
and chronic diseases and injuries in 188 countries, 1990-2013: a systematic
analysis for the Global Burden of Disease Study 2013, Lancet 2015.
[5] Mozaffarian D, Benjamin EJ, Go AS, et al. Heart Disease and Stroke
Statistics-2016 Update: A report from the American Heart Association.
Circulation. 2015; 132:000-000. doi: 10.1161/CIR.0000000000000350.
[6] Wier LM, Pfuntner A, Maeda J, et al. HCUP facts and figures: statistics on
hospital-based care in the United States, 2009. Rockville, MD: Agency for
Healthcare Research and Quality, 2011.
[7] Owan TE, Hodge DO, Herges RM, et al. Trends in prevalence and outcome of
heart failure with preserved ejection fraction. N Engl J Med. 2006;355:251-259.
[8] Ejection Fraction Heart Failure Measurement. American Heart Association
Website.
http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosisofHeartFa
ilure/Ejection-Fraction-Heart-Failure-Measurement_UCM_306339_Article.jsp.
Published March 24, 2015. Accessed March 10, 2016.
[9] Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the impact of heart
failure in the United States: a policy statement from the American Heart
Association. Circ Heart Fail. 2013;6:606-619.
[10] Entresto Prescribing Information.
[11] Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the
management of heart failure: A report of the American College of Cardiology
Foundation/American Heart Association task force on practice guidelines.
Circulation. 2013;128:e240-e327.
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Datum: 21.05.2016 - 02:01 Uhr
Sprache: Deutsch
News-ID 472701
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