PARIS and TARRYTOWN, N.Y.,
Nov. 7, 2018 /PRNewswire/
-- The New England Journal of Medicine (NEJM)
today published positive detailed results of the 18,924-patient
ODYSSEY OUTCOMES trial.
The trial met its primary endpoint, showing that
Praluent® (alirocumab) Injection significantly reduced
the risk of major adverse cardiovascular events (MACE) in patients
who had suffered an acute coronary syndrome (ACS), which included a
heart attack or unstable angina. 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).
Death from any cause was less frequent among Praluent-treated
patients. Praluent was associated with a 15% lower risk of death;
death 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).1
The NEJM publication also includes results for MACE and
other secondary endpoints including death, according to subgroups
of baseline LDL-C (low-density lipoprotein cholesterol) levels,
which are described in detail in the Supplementary Appendix. The
data showed that patients with higher LDL-C at baseline (at least
100 mg/dL) were at greater risk of MACE, as well as other secondary
endpoints including death. Moreover, the greater risk-reduction
occurred in this category of patients: in the Praluent group MACE
was reduced by 24% (HR 0.76; 95% CI, 0.65 to 0.87) and death from
any cause was 29% lower (HR 0.71; 95% CI, 0.56 to 0.90) compared to
placebo2.
Adverse events were similar between groups except for injection
site reactions (Praluent 3.8%, placebo 2.1%).
Results of the ODYSSEY OUTCOMES trial were presented at the
American College of Cardiology's 67th Annual Scientific Session
& Expo in March 2018. Additional
analyses, including mortality, will be presented later this week at
the American Heart Association Scientific Sessions 2018.
"Despite the use of statins,
many patients with coronary heart disease go on to have recurrent
cardiovascular events, underscoring the need for additional
treatment options. This need is particularly urgent among patients
with acute coronary syndrome and LDL-C levels that remain high
despite best possible application of statin therapy," said Dr.
Gregory G. Schwartz, M.D., Ph.D.,
University of Colorado School of
Medicine, Aurora, CO, and co-chair
of the trial. "These data in the New England Journal of Medicine
show that adding alirocumab to intensive or maximum tolerated
statin treatment significantly reduced the risk of future
cardiovascular events. This benefit was heightened among study
patients with higher LDL-C levels at baseline."
The effect of Praluent on cardiovascular morbidity and mortality
is currently being reviewed by regulatory authorities and has not
yet been fully evaluated. Data from the ODYSSEY OUTCOMES trial has
been submitted to regulatory authorities in the European Union and
in the U.S., where the target action date for the Food and Drug
Administration (FDA) decision is April 28,
2019.
Click here for additional information on the ODYSSEY OUTCOMES
trial and Praluent.
Indication
Praluent is approved in more than 60 countries worldwide,
including the U.S., Japan,
Canada, Switzerland, Mexico and Brazil, as well as the European Union (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
atherosclerotic cardiovascular disease (ASCVD) who require
additional lowering of LDL-C. The effect of Praluent on
cardiovascular morbidity and mortality has not been determined.
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 by physician-scientists for 30 years, our unique
ability to repeatedly and consistently translate science into
medicine has led to six FDA-approved treatments and over a dozen
product candidates, all of which were homegrown in our
laboratories. Our medicines and pipeline are designed to help
patients with eye disease, heart disease, allergic and inflammatory
diseases, pain, cancer, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through its proprietary VelociSuite®
technologies, including VelocImmune® to yield optimized
fully-human antibodies, and ambitious initiatives such as the
Regeneron Genetics Center, 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 (EURONEXT: SAN) (NYSE: SNY) 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
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1
|
Analyses for the
death endpoints in the overall study fell outside of the
statistical hierarchy; and in accordance with recently implemented
NEJM policies, the hazard ratio (HR) and its confidence
interval (CI) were published, but no P-values were
reported.
|
2
|
Analyses of the death
endpoint based on baseline LDL-C levels were not included in the
statistical hierarchy; and in accordance with recently implemented
NEJM policies, the hazard ratio (HR) and its confidence
interval (CI) were published, but no P-values were
reported.
|
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