Sanofi: CHMP recommends approval of Praluent® (alirocumab) to reduce cardiovascular risk in people with established atherosc...
04 Febrero 2019 - 12:01AM
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 OUTCOMESODYSSEY 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 PraluentPraluent inhibits the
binding of PCSK9 (proprotein convertase subtilisin/kexin type 9)
tothe LDL receptor and thereby increases the number of available
LDL receptors on thesurface 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 KressmannTel: +1
(732) 532-5318Nicolas.Kressmann@sanofi.com
Regeneron Media Relations
ContactSarah CornhillTel: +1 (914)
847-5018Sarah.Cornhill@regeneron.com |
Sanofi Investor
Relations Contact George Grofik Tel: +33 (0)1 53 77 45 45
ir@sanofi.com Regeneron Investor Relations ContactMark
HudsonTel: +1 (914) 847-3482 Mark.Hudson@regeneron.com |
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