- Entresto is the first and only therapy approved in the US to
treat patients diagnosed with guideline-defined heart failure to
include both those with heart failure with reduced ejection
fraction (HFrEF) and many with heart failure with preserved
ejection fraction (HFpEF)1-3
- Expanded indication enables potential treatment of more adults
with left ventricular ejection fraction (LVEF) below normal, the
group where benefits are most clearly evident1
- Of the more than 6 million Americans suffering from chronic
heart failure (CHF), approximately 5 million may be appropriate for
treatment with Entresto3,4
Basel, February 16, 2021 — Novartis today
announced that the US Food and Drug Administration (FDA) has
approved the following expanded indication for Entresto®
(sacubitril/valsartan): to reduce the risk of cardiovascular death
and hospitalization for heart failure in adult patients with
chronic heart failure1. Benefits are most clearly evident in
patients with left ventricular ejection fraction (LVEF) below
normal1. The label also states LVEF is a variable measure and
clinical judgment should be used in deciding whom to treat1.
For the first time, there is a treatment with benefit for
patients diagnosed with guideline-defined heart failure that
includes both those with heart failure with reduced ejection
fraction (HFrEF) and many with heart failure with preserved
ejection fraction (HFpEF)1-3.
“This approval is a significant advancement, providing a
treatment to many patients who were not eligible for treatment
before because their ejection fraction was above the region we
normally considered reduced. Until now, treatment for these
patients was largely empiric,” said Scott Solomon, MD, Professor of
Medicine at Harvard Medical School and Brigham and Women's
Hospital, and PARAGON-HF Executive Committee Co-Chair. “We can now
offer a treatment to a wider range of patients who have an LVEF
below normal.”
This label expansion is based on efficacy and safety evidence
observed in PARAGON-HF, the largest and only Phase III
active-controlled study to date in patients with guideline-defined
HFpEF2,5,6. The greatest benefit was shown in patients with LVEF
below normal6.
Approximately 6 million Americans are living with chronic heart
failure (CHF)4. Approximately 3 million have HFrEF, and of the
remaining 3 million, about 2 million have HFpEF with LVEF below
normal2-4. The prevalence of heart failure (HF) is increasing as
the population ages4. Patients often face worsening symptoms that
result in frequent HF hospitalizations7. Each hospitalization event
is associated with worsening long-term prognosis7. Approximately
one in four patients are re-admitted for HF and 10 percent may die
within 30 days of discharge8,9. Overall CHF death rates remain
significantly high, with up to half of patients dying within five
years of a HF diagnosis4.
“We are proud of our goal to reimagine medicine. This commitment
has enabled us to bring Entresto to millions more heart failure
patients in the US, many of whom did not have an approved treatment
option until now,” said Marie-France Tschudin, President, Novartis
Pharmaceuticals. “This achievement would not have been possible
without tremendous dedication from investigators, patients in our
clinical trials and the advocacy community, to whom we are
extremely grateful.”
About our longstanding commitment to heart
failureOur goal is to reimagine medicine for heart failure
patients. Novartis established the largest global clinical program
in the HF disease area across the pharma industry to date. Known as
FortiHFy, it is comprised of more than 40 clinical studies designed
to generate an array of additional data on efficacy, quality of
life, patient-reported outcomes and real-world evidence with
Entresto, as well as to extend understanding of heart failure.
FortiHFy includes trials across the spectrum of heart failure, such
as PARADIGM-HF, PIONEER-HF, TRANSITION, PROVE-HF, PARAGON-HF and
PARAMOUNT. Worldwide, it is estimated that more than 30,000
patients have participated in the Entresto clinical trials program,
and it is estimated that more than 2.8 million patients are on
treatment with Entresto today.
About EntrestoIn Europe, Entresto is indicated
in adult patients for the treatment of symptomatic chronic HF with
reduced ejection fraction10. In the United States, Entresto is
indicated to reduce the risk of cardiovascular death and
hospitalization for heart failure in adult patients with chronic
heart failure1. Benefits are most clearly evident in patients with
left ventricular ejection fraction (LVEF) below normal1. LVEF is a
variable measure, so use clinical judgment in deciding whom to
treat1. Approved indications may vary depending upon the individual
country.
Entresto is a twice-a-day medicine that reduces the strain on
the failing heart10. It does this by enhancing protective
neurohormonal systems (i.e., natriuretic peptide system) while
simultaneously inhibiting the harmful effects of the overactive
renin-angiotensin-aldosterone system (RAAS)10,11. Other common HF
medicines, called angiotensin converting enzyme inhibitors (ACEi)
and angiotensin II receptor blockers (ARBs), only block the harmful
effects of the overactive RAAS. Entresto contains the neprilysin
inhibitor sacubitril and the angiotensin receptor blocker (ARB)
valsartan1,10.
DisclaimerThis 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,” “may,” “could,” “would,” “commitment,”
“to reduce,” “increasing,” “goal,” “to generate,” or similar terms,
or by express or implied discussions regarding potential marketing
approvals, 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 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 Entresto
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 Entresto will be commercially
successful in the future. In particular, our expectations regarding
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; 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 NovartisNovartis 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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https://www.novartis.com/news/media-libraryFor
questions about the site or required registration, please contact
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References
- ENTRESTO [prescribing information]. East Hanover, NJ: Novartis
Pharmaceuticals Corp; February 2021.
- Yancy C, Jessup M, Bozkurt B. 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.
https://doi.org/10.1161/CIR.0b013e31829e8776
- Fonarow G, Stough W, Abraham W, et al. Characteristics,
treatments, and outcomes of patients with preserved systolic
function hospitalized for heart failure: a report from the
OPTIMIZE-HF registry. J Am Coll Cardiol. 2007;50:768-777.
doi:10.1016/j.jacc.2007.04.064
- Virani S, Alonso A, Benjamin E, et al. Heart disease and stroke
statistics-2020 update: a report from the American Heart
Association. Circulation. 2020;141:e139-e596.
doi:10.1161/CIR.0000000000000757
- Solomon S, Rizkala A, Gong J, et al. Angiotensin receptor
neprilysin inhibition in heart failure with preserved ejection
fraction: rationale and design of the PARAGON-HF trial. JACC Heart
Fail. 2017;5(7):471-482. doi:10.1016/j.jchf.2017.04.013
- Solomon S, McMurray J, Anand I, et al. Angiotensin-neprilysin
in heart failure with preserved ejection fraction. N Engl J Med.
2019;381:1609-1620. doi:10.1056/NEJMoa1908655
- Gheorghiade M, De Luca L, Fonarow G, et al. Pathophysiologic
targets in the early phase of acute heart failure syndromes. Am J
Cardiol. 2005;96(6A):11G-17G.
- Dharmarajan K, Hsieh A, Lin Z, et al. Diagnoses and timing of
30-day readmissions after hospitalization for heart failure, acute
myocardial infarction, or pneumonia. JAMA. 2013;309(4):355-363.
doi:10.1001/jama.2012.216476
- Bueno H, Ross J, Wang Y, et al. Trends in length of stay and
short-term outcomes among Medicare patients hospitalized for heart
failure: 1993-2008. JAMA. 2010;303(21):2141-2147.
doi:10.1001/jama.2010.748
- EMA. Entresto (sacubitril/valsartan). Summary of product
characteristics. Accessed July
2019. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004062/WC500197536.pdf
- Langenickel T, Dole W. Angiotensin receptor-neprilysin
inhibition with LCZ696: a novel approach for the treatment of heart
failure. Drug Discov Today. 2012;9(4):e131-e139.
doi:10.1016/j.ddstr.2013.11.002
# # #
Novartis Media RelationsE-mail:
media.relations@novartis.com
Anja von
TreskowNovartis External Communications+41 61 324 2279
(direct)E-mail: anja.von_treskow@novartis.com Julie
MasowNovartis US External Communications+1 862 579
8456Julie.masow@novartis.com |
Phil McNamaraGlobal
Head, Cardio-Renal-Metabolism Communications+41 79 510 8756
(mobile)E-mail: phil.mcnamara@novartis.com |
Novartis Investor RelationsCentral investor
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investor.relations@novartis.com
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