Novartis announces investment in FortiHFy clinical program of Entresto® and heart failure
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Novartis International AG /
Novartis announces investment in FortiHFy clinical program of Entresto® and
heart failure
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* Fortifying Heart Failure clinical evidence and patient quality of life
(FortiHFy) is an umbrella clinical program comprising over 40 active or
planned trials
* The global clinical program will generate additional data on symptom
reduction, efficacy, safety, quality of life benefits and real world
evidence with Entresto
* Investigators and patients from over 50 countries to participate over 5
years
Basel, May 19, 2016 - Novartis today announced the establishment of FortiHFy,
the largest global clinical program in the heart failure disease area across the
pharma industry to date, 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 its novel heart failure
medicine Entresto(® )(sacubitril/valsartan), and extend understanding of heart
failure.
"The FortiHFy program reinforces our long term commitment to improving heart
failure treatment for as many people as possible," said Vas Narasimhan Global
Head, Drug Development and Chief Medical Officer. "The outcomes of these trials
will increase our understanding of heart failure, the patient population who may
benefit from Entresto, and could potentially support applications to regulatory
authorities".
Major trials in the FortiHFy program include:
* PARAGON-HF examining the efficacy and safety of Entresto in heart failure
patients with with preserved ejection fraction (compared to valsartan),
expected study completion in 2019
* PARADISE-MI testing the hypothesis that Entresto can reduce cardiovascular
death, heart failure hospitalizations and new onset heart failure in
patients at high risk for heart failure after a myocardial infarction,
expected study completion in 2020
* TRANSITION comparing in-hospital initiation of Entresto to initiation after
hospital discharge in heart failure patients with reduced ejection fraction
(HFrEF) who have recently been hospitalized for acute decompensation,
expected study completion in 2018
* PIONEER investigating the effect of in-hospital initiation of Entresto on
changes in NT-proBNP (compared to enalapril) in patients with HFrEF
following an acute decompensation, expected study completion in 2018
FortiHFy trials that are already active are posted on clinicaltrials.gov and are
currently enrolling patients in more than 50 countries worldwide. Entresto is
approved in 57 countries to date for the treatment of heart failure with reduced
ejection fraction (HFrEF), based on data from the PARADIGM-HF study which
reported results in 2014[1].
About Heart Failure
Heart failure is a debilitating and life-threatening condition, which impacts
over 60 million people worldwide[2]. It is the leading cause of hospitalization
in people over the age of 65[3],[4]. About half of people with heart failure
have HFrEF[5]. Reduced ejection fraction means the heart does not contract with
enough force, so less blood is pumped out[6]. Heart failure presents a major and
growing health-economic burden that currently costs the world economy $108
billion every year[3],[7].
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)[8]. Other heart failure medicines
only block the harmful effects of the overactive RAAS[9]. Entresto contains the
neprilysin inhibitor sacubitril, which is a new molecular entity, and the
angiotensin receptor blocker (ARB) valsartan[8].
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[8]. 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.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "planned," "will," "to participate," "designed to," "long
term," "commitment," "may," "potential," "could," "potentially," or similar
terms, or by express or implied discussions regarding the commencement or
completion of additional clinical trials of Entresto, or 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 any or all of the clinical trials
discussed in this release will be commenced or completed, or that they will be
commenced or completed in the manner or time described or implied in this
release. 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 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; unexpected resistance to
Entresto by payors or prescribers; the company's ability to obtain or maintain
proprietary intellectual property protection; general economic and industry
conditions; competition in general; global trends toward health care cost
containment, including ongoing pricing pressures; unexpected safety,
manufacturing or quality 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] McMurray JJV et al. Angiotensin-Neprilysin Inhibition versus Enalapril in
Heart Failure, N Engl J Med 2014.
[2] 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.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] Entresto Prescribing Information.
[9] 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: 19.05.2016 - 07:15 Uhr
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News-ID 472188
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