Sanofi: CHMP recommends approval of Praluent® (alirocumab) to reduce cardiovascular risk in people with established atherosc...
04 Febrero 2019 - 12:00AM
CHMP recommends approval of
Praluent® (alirocumab)
to reduce cardiovascular risk in people with established
atherosclerotic cardiovascular disease
PARIS and
TARRYTOWN, NY - February 4, 2019 - The European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) has
adopted a positive opinion for Praluent® (alirocumab),
recommending a new indication as an adjunct to correction of other
risk factors. Praluent should be used in addition to a maximally
tolerated dose of statin or can be used alone in patients
intolerant to or inappropriate for statin therapy.
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.
The CHMP opinion is based on data
from ODYSSEY OUTCOMES, a Phase 3 cardiovascular outcomes trial that
assessed the effect of Praluent 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 European Commission is
expected to make a final decision in the coming months. Data from
ODYSSEY OUTCOMES has 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 major adverse cardiovascular events (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 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 EU, U.S., Japan, Canada,
Switzerland, Mexico and Brazil. 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.
In the EU, Praluent has been
initially approved for the treatment of adult patients with primary
hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia
as an adjunct to diet: a) in combination with a statin, or statin
with other lipid-lowering therapies in patients unable to reach
their LDL-C goals with the maximally-tolerated statin or b) alone
or in combination with other lipid-lowering therapies for patients
who are statin intolerant, or for whom a statin is
contraindicated.
This medicinal product is subject
to additional monitoring. This will allow quick identification of
new safety information. Healthcare professionals are asked to
report any suspected adverse reactions.
The results of ODYSSEY OUTCOMES,
which evaluated the effect of Praluent on cardiovascular morbidity
and mortality, are currently under evaluation by a number of
regulatory authorities worldwide. To date, only the CHMP has
completed its assessment.
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
Sarah Cornhill
Tel: +1 (914) 847-5018
Sarah.Cornhill@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 and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
performance. 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, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities, to
complete related transactions and/or obtain regulatory clearances,
risks associated with intellectual property and any related pending
or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic conditions, the impact of cost containment
initiatives and subsequent changes thereto, the average number of
shares outstanding as well as those 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, 2017. 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
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 impact of the opinion adopted by the
European Medicines Agency's Committee for Medicinal Products for
Human Use discussed in this press release on the European
Commission's decision regarding the Marketing Authorization
Application for Praluent to [reduce cardiovascular risk by lowering
low-density lipoprotein cholesterol levels in adults with
established atherosclerotic cardiovascular disease]; 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, including possible new
regulatory approvals of Praluent in the European Union and by the
U.S. Food and Drug Administration (the "FDA") discussed 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; 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; uncertainty of market
acceptance and commercial success of Regeneron's products 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 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 to
perform filling, finishing, packaging, labeling, distribution, and
other steps related to 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; 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, 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. 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). |
Press release (PDF)
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Sanofi via Globenewswire
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