TARRYTOWN, N.Y. and
PARIS, March 15, 2019 /PRNewswire/ --
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
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi today announced that 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.
"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."
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.
"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."
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 2 weeks and can also be administered as 300 mg once every 4
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)
Injection 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 and invented by Regeneron using the company's proprietary
VelocImmune® technology that yields
optimized fully-human monoclonal antibodies.
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 factors. 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.
Important Safety Information for U.S. Patients
Do not
use Praluent if you are allergic to alirocumab or to any of the
ingredients in Praluent.
Before you start using Praluent, tell your healthcare provider
about all your medical conditions, including allergies, and if you
are pregnant or plan to become pregnant or if you are breastfeeding
or plan to breastfeed.
Tell your healthcare provider or pharmacist about any
prescription and over-the-counter medicines you are taking or plan
to take, including natural or herbal remedies.
Praluent can cause serious side effects, including allergic
reactions that can be severe and require treatment in a hospital.
Call your healthcare provider or go to the nearest hospital
emergency room right away if you have any symptoms of an allergic
reaction including a severe rash, redness, severe itching, a
swollen face, or trouble breathing.
The most common side effects of Praluent include: redness,
itching, swelling, or pain/tenderness at the injection site,
symptoms of the common cold, and flu or flu-like symptoms. Tell
your healthcare provider if you have any side effect that bothers
you or that does not go away.
Talk to your doctor about the right way to prepare and give
yourself a Praluent injection and follow the "Instructions for Use"
that comes with Praluent.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for the full Prescribing
Information.
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
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).
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
Contacts:
|
Sanofi
Contacts:
|
|
|
Media
Relations
|
Media
Relations
|
|
|
Joe
Ricculli
|
Nicolas
Kressmann
|
Tel: +1 (914)
847-0405
|
Tel: +1 (732)
532-5318
|
joseph.ricculli@regeneron.com
|
nicolas.kressmann@sanofi.com
|
|
|
Investor
Relations
|
Investor
Relations
|
Mark
Hudson
|
George
Grofik
|
Tel: +1 (914)
847-3482
|
Tel: +33 (0)1 53 77
45 45
|
mark.hudson@regeneron.com
|
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.