TARRYTOWN, N.Y. and
PARIS, April 26, 2019 /PRNewswire/ --
- Praluent is the first PCSK9 inhibitor that has shown a
meaningful reduction in death from any cause
- Praluent treatment effect was observed in patients already
receiving other lipid-lowering therapies, including
maximally-tolerated statins
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi today announced that the U.S. Food and Drug Administration
(FDA) has approved Praluent® (alirocumab) to reduce the
risk of heart attack, stroke and unstable angina requiring
hospitalization in adults with established cardiovascular (CV)
disease.
"Heart disease accounts for one quarter of all American deaths
each year and many others are at risk for heart attack and stroke
due to uncontrolled LDL-C levels," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer, Regeneron. "The Phase 3 ODYSSEY
OUTCOMES trial showed that people who received Praluent
significantly reduced their risk for serious cardiovascular events.
There was also a clinically-meaningful reduction in death from any
cause with Praluent treatment. With this approval, and the recent
introduction of a lower U.S. Praluent list price, we hope that more
patients in need will be able to access Praluent."
High levels of "bad" cholesterol, also known as low-density
lipoprotein cholesterol (LDL-C), increase patients' risk for
serious CV events such as heart attack or stroke. Adults who
experience a heart attack or stroke have an approximately one in
three chance to have another CV event.
"Today's FDA approval marks a significant achievement in the
treatment of adults with established cardiovascular disease, who
are among those at greatest risk of death or disability caused by
serious cardiovascular events," said John
Reed, M.D., Ph.D., Global Head of Research &
Development, Sanofi. "Praluent has already helped many adults lower
their LDL-C levels, and this new indication provides an opportunity
to help appropriate patients by reducing the risk of serious,
life-threatening cardiovascular events, including heart attacks and
stroke."
The FDA approval is based on data from ODYSSEY OUTCOMES, which
was published in the New England Journal of Medicine in
November 2018, assessing the effect
of adding Praluent to maximally-tolerated statins on CV outcomes in
18,924 patients who had an acute coronary syndrome (ACS) within a
year of enrolling in the trial. Patients who received Praluent in
the trial experienced:
- A 15% reduced risk for major CV events. The primary endpoint
included time to first heart attack, stroke, death from coronary
heart disease (CHD), or unstable angina requiring hospitalization
(HR 0.85; 95% CI, 0.78 to 0.93; p=0.0003).
- A 27% reduced risk of stroke, 14% reduced risk of non-fatal
heart attack and 39% reduced risk of unstable angina requiring
hospitalization.*
- A 15% reduced risk of death from any cause (also called
all-cause mortality; HR 0.85; 95% CI, 0.73 to 0.98; nominal
p=0.026) was also observed.*
*Because statistical testing of these endpoints was performed
outside of the hierarchy, the results are not considered
statistically significant.
Adverse events were similar between the Praluent and placebo
groups, except for injection site reactions (Praluent 3.8%, placebo
2.1%). In ODYSSEY OUTCOMES, the adverse events that occurred in
>5% of patients included: non-cardiac chest pain (7.0% Praluent,
6.8% placebo), nasopharyngitis (6.0% Praluent, 5.6% placebo) and
myalgia (5.6% Praluent, 5.3% placebo).
The FDA also approved Praluent as an adjunct to diet, alone or
in combination with other lipid-lowering therapies (e.g., statins,
ezetimibe), for the treatment of adults with primary hyperlipidemia
(including heterozygous familial hypercholesterolemia) to reduce
LDL-C.
Praluent was the first PCSK9 (proprotein convertase
subtilisin/kexin type 9) inhibitor approved by the FDA and is the
only PCSK9 inhibitor available in two doses with two levels of
efficacy as a single 1 mL injection (75 mg and 150 mg) once every
two weeks. It 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.
About ODYSSEY OUTCOMES
ODYSSEY OUTCOMES, the longest
CV outcomes trial of any PCSK9 inhibitor to date, assessed the
effect of Praluent on the occurrence of major adverse CV events 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 five years.
Approximately 90% of patients were on high-intensity statins prior
to randomization.
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 two weeks and switched to 150 mg every two
weeks if their LDL-C levels remained above 50 mg/dL (n=2,615). Some
patients who switched to 150 mg switched back to 75 mg if their
LDL-C fell below 25 mg/dL (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 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 U.S., European Union (EU), Japan, Canada, Switzerland, Mexico and Brazil. In the U.S., Praluent is approved to
reduce the risk of heart attack, stroke and unstable angina
requiring hospitalization in adults with established CV disease.
Praluent is also approved as an adjunct to diet, alone or in
combination with other lipid lowering therapies (e.g., statins,
ezetimibe), for the treatment of adults with primary hyperlipidemia
(including heterozygous familial hypercholesterolemia) to reduce
LDL-C.
Important Safety Information for the U.S.
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; uncertainty of market acceptance
and commercial success of Regeneron's products and product
candidates, such as Praluent (including any impact of the U.S. Food
and Drug Administration approval discussed in this press release on
the commercialization of Praluent); 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, such
as private payer healthcare and insurance programs, health
maintenance organizations, pharmacy benefit management companies,
and government programs such as Medicare and Medicaid (including
any impact of the pricing strategy for Praluent referenced in this
press release); 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
Joe
Ricculli
Tel: +1 (914)
847-0405
joseph.ricculli@regeneron.com
Investor
Relations
Mark
Hudson
Tel: +1 (914)
847-3482
mark.hudson@regeneron.com
|
Media
Relations Nicolas Kressmann
Tel: +1 (732) 532-5318
nicolas.kressmann@sanofi.com
Investor
Relations
George
Grofik
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
View original
content:http://www.prnewswire.com/news-releases/fda-approves-praluent-alirocumab-to-prevent-heart-attack-stroke-and-unstable-angina-requiring-hospitalization-300839345.html
SOURCE Regeneron Pharmaceuticals, Inc.