Praluent® (alirocumab) now approved in European Union to reduce the risk of cardiovascular events in patients with establish...
15 Marzo 2019 - 5:40PM
Praluent® (alirocumab)
now approved in European Union to reduce the risk of cardiovascular
events in patients with established cardiovascular disease
- Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients
who recently suffered an acute coronary syndrome such as a heart
attack
- Praluent is the only EU-approved PCSK9 inhibitor with
cardiovascular outcomes data that showed an association with
reduced death from any cause
PARIS and TARRYTOWN, NY - March 15, 2019 -
The European Commission (EC) has approved a new
indication for Praluent® (alirocumab), to reduce
cardiovascular (CV) risk in adults with established atherosclerotic
CV disease (ASCVD) by lowering low-density lipoprotein cholesterol
(LDL-C) levels as an adjunct to correction of other risk
factors.
"Many patients with atherosclerotic cardiovascular disease often
struggle to control their high LDL-cholesterol levels, despite
lifestyle modifications and treatment with statins, and some have
already experienced cardiovascular events," said John Reed,
M.D., Ph.D., Global Head of Research & Development,
Sanofi. "These patients could face a higher risk of another
life-threatening cardiovascular event, and Praluent's new
indication in Europe offers a risk-reduction focused lipid-lowering
treatment option to physicians and patients."
ASCVD is an umbrella term, defined as a build-up of plaque in
the arteries that can lead to reduced blood flow and a number of
serious conditions such as stroke, peripheral artery disease and
acute coronary syndrome (ACS), which includes heart attack and
unstable angina.
"Despite treatment with the current standard of care including
statins, many Europeans with established cardiovascular disease are
still unable to control their cholesterol," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer,
Regeneron. "In the large, prospective ODYSSEY OUTCOMES
clinical trial, Praluent reduced the risk of major cardiovascular
events, including heart attack, stroke and unstable angina, and was
associated with reduced death from any cause."
The EC approval is based on data from ODYSSEY OUTCOMES, a Phase
3 CV outcomes trial that assessed the effect of adding Praluent to
maximally-tolerated statins in 18,924 patients who had an ACS
between 1-12 months (median 2.6 months) before enrolling in the
trial. Results from the ODYSSEY OUTCOMES trial
were published in The New England Journal of
Medicine in 2018. The trial met its primary endpoint, showing
that Praluent significantly reduced the relative risk of major
adverse CV events (MACE) by 15% in patients who had suffered a
recent ACS. MACE occurred in 903 patients (9.5%) in the Praluent
group and in 1,052 patients (11.1%) in the placebo group (HR 0.85;
95% CI, 0.78 to 0.93; p<0.001). Additionally, Praluent was
associated with a 15% lower risk of death from any cause; which
occurred in 334 (3.5%) patients in the Praluent group and 392
(4.1%) patients in the placebo group (HR 0.85; 95% CI, 0.73 to
0.98; nominal significance). Adverse events were similar between
the Praluent and placebo groups, except for injection site
reactions (Praluent 3.8%, placebo 2.1%).
Praluent is the only PCSK9 (proprotein convertase
subtilisin/kexin type 9) inhibitor available in two starting doses
as a single 1 milliliter (mL) injection (75 mg and 150 mg) once
every two weeks and can also be administered as 300 mg once every
four weeks (monthly), enabling physicians to tailor treatment based
on an individual patient's LDL-C-lowering needs. Data from ODYSSEY
OUTCOMES have also been submitted to the U.S. Food and Drug
Administration (FDA), with a target action date of April 28,
2019.
About ODYSSEY OUTCOMES ODYSSEY OUTCOMES
assessed the effect of Praluent on the occurrence of MACE in
patients who had experienced an ACS before enrolling in the trial,
and who were already on intensive or maximally-tolerated statin
treatment. Patients were randomized to receive Praluent (n=9,462)
or a placebo (n=9,462) and were assessed for a median of 2.8 years,
with some patients being treated for up to 5 years. Approximately
90% of patients were on a high-intensity statin.
The trial was designed to maintain patients' LDL-C levels
between 25-50 mg/dL (0.65-1.29 mmol/L), using two different doses
of Praluent (75 mg and 150 mg). Praluent-treated patients started
the trial on 75 mg every 2 weeks and switched to 150 mg every 2
weeks if their LDL-C levels remained above 50 mg/dL (1.29 mmol/L)
(n=2,615). Some patients who switched to 150 mg switched back to 75
mg if their LDL-C fell below 25 mg/dL (0.65 mmol/L) (n=805), and
patients who experienced two consecutive LDL-C measurements below
15 mg/dL (0.39 mmol/L) while on the 75 mg dose (n=730) stopped
active Praluent therapy for the remainder of the trial.
About Praluent Praluent® (alirocumab)
inhibits the binding of PCSK9 (proprotein convertase
subtilisin/kexin type 9) to the LDL receptor and thereby increases
the number of available LDL receptors on the surface of liver cells
to clear LDL, which lowers LDL-C levels in the blood. Praluent was
developed by Regeneron and Sanofi under a global collaboration
agreement.
Praluent is approved in more than 60 countries worldwide,
including the European Union (EU), U.S., Japan, Canada,
Switzerland, Mexico and Brazil. In the EU, Praluent is approved for
use to reduce CV risk in adults with established ASCVD by lowering
LDL-C, as an adjunct to correction of other risk factor. The effect
of Praluent on CV morbidity and mortality is currently under review
and not yet approved by any regulatory authority outside of the
EU.
In the U.S., Praluent is approved for use as an adjunct to diet
and maximally tolerated statin therapy for the treatment of adults
with heterozygous familial hypercholesterolemia (HeFH) or clinical
ASCVD who require additional lowering of LDL-C.About
Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for 30 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neuromuscular
diseases, infectious diseases and rare diseases. Regeneron is
accelerating and improving the traditional drug development process
through our proprietary VelociSuite® technologies, such
as VelocImmune® which produces optimized fully-human
antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world. For additional
information about the company, please
visit www.regeneron.com or follow @Regeneron on
Twitter.
About
Sanofi Sanofi is dedicated to supporting people through
their health challenges. We are a global biopharmaceutical company
focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by
the few who suffer from rare diseases and the millions with
long-term chronic conditions. With more than 100,000 people in 100
countries, Sanofi is transforming scientific innovation into
healthcare solutions around the globe. Sanofi, Empowering Life |
Sanofi Media
Relations Contact Nicolas Kressmann Tel: +1 (732) 532-5318
nicolas.kressmann@sanofi.com Regeneron Media Relations
Contact Joseph Ricculli Tel: +1 (914) 847-0405
joseph.ricculli@regeneron.com |
Sanofi Investor
Relations Contact George Grofik Tel: +33 (0)1 53 77 45 45
ir@sanofi.com Regeneron Investor Relations Contact
Mark Hudson Tel: +1 (914) 847-3482
mark.hudson@regeneron.com |
Sanofi Forward-Looking Statements This press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31, 2018. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements. Regeneron Forward-Looking Statements and Use of
Digital Media This press release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements.
Words such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these
risks and uncertainties include, among others, the nature, timing,
and possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Praluent® (alirocumab) Injection; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for
marketed products, such as possible approval by the U.S. Food and
Drug Administration (the "FDA") of the update to the Prescribing
Information for Praluent to include the effect of Praluent in
reducing the overall risk of major adverse cardiovascular events
referenced in this press release; the impact of the recent and any
potential future U.S. government shutdowns on the anticipated
timing of the FDA regulatory action relating to Praluent referenced
in this press release; uncertainty of market acceptance and
commercial success of Regeneron's products (such as Praluent) and
product candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's products and product candidates;
the availability and extent of reimbursement of the Company's
products (such as Praluent) from third-party payers, including
private payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; unforeseen safety issues
resulting from the administration of products and product
candidates in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; the extent to which the results from
the research and development programs conducted by Regeneron or its
collaborators may be replicated in other studies and lead to
therapeutic applications; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products (such as
Praluent), research and clinical programs, and business, including
those relating to patient privacy; determinations by regulatory and
administrative governmental authorities which may delay or restrict
Regeneron's ability to continue to develop or commercialize
Regeneron's products and product candidates, including without
limitation Praluent; competing drugs and product candidates that
may be superior to Regeneron's products and product candidates; the
ability of Regeneron to manufacture and manage supply chains for
multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's products and product candidates; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its financial projections
or guidance and changes to the assumptions underlying those
projections or guidance; risks associated with intellectual
property of other parties and pending or future litigation relating
thereto, including without limitation the patent litigation and
other proceedings relating to Praluent, EYLEA® (aflibercept)
Injection, and Dupixent® (dupilumab) Injection, the ultimate
outcome of any such proceedings, and the impact any of the
foregoing may have on Regeneron's business, prospects, operating
results, and financial condition; and the potential for any license
or collaboration agreement, including Regeneron's agreements with
Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their
respective affiliated companies, as applicable), to be cancelled or
terminated without any further product success. A more complete
description of these and other material risks can be found in
Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31,
2018. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to
update publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise. Regeneron
uses its media and investor relations website and social media
outlets to publish important information about the Company,
including information that may be deemed material to investors.
Financial and other information about Regeneron is routinely posted
and is accessible on Regeneron's media and investor relations
website (http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron). |
Attachment
Sanofi (EU:SAN)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Sanofi (EU:SAN)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024