Sanofi: ODYSSEY OUTCOMES investigators highlight at AHA that Praluent® (alirocumab) was associated with fewer deaths from an...
11 Noviembre 2018 - 7:17AM
ODYSSEY OUTCOMES investigators highlight at AHA that
Praluent® (alirocumab) was associated with fewer deaths from any
cause
- Mortality risk reduction greater in patients treated for at
least 3 years or those with baseline LDL-C levels of at least 100
mg/dL
- New analyses show reduction in non-fatal cardiovascular events
is associated with a subsequent reduction in non-cardiovascular
death
PARIS and Tarrytown, N.Y. - November 11,
2018 - New analyses on mortality from the 18,924-patient
ODYSSEY OUTCOMES trial were presented at the American Heart
Association (AHA) Scientific Sessions 2018.
Praluent® (alirocumab) was associated with fewer
deaths from any cause among patients who had previously experienced
a heart attack or unstable angina (known as acute coronary
syndrome, or ACS), and this was enhanced in patients who were
followed for at least 3 years and those who had an LDL-C
(low-density lipoprotein cholesterol) of 100 mg/dL or higher at
baseline. Moreover, additional new analyses showed an association
between reduced non-fatal cardiovascular (CV) events and reduction
in non-CV death during the trial period.
"Reducing patients' risk of death is one of
cardiologists' key priorities. Some of these deaths could
potentially be prevented, particularly among patients who have
already been identified as high risk because they have a history of
acute coronary syndrome," said Gregory G. Schwartz, M.D., Ph.D.,
University of Colorado School of Medicine, Aurora, CO, and co-chair
of the trial. "In this nearly 19,000-patient trial, alirocumab was
associated with fewer deaths from any cause, an observation that
was more pronounced among patients who were eligible for at least 3
years of treatment, or who started with LDL-C of at least 100
mg/dL."
In the trial, Praluent added to
maximally-tolerated statins was compared to maximally-tolerated
statins alone in patients who had experienced an ACS within the
last 12 months. Data published in The New England Journal of
Medicine last week found Praluent significantly reduced the risk of
major adverse cardiovascular events (MACE) and was associated with
a lower risk of death from any cause.
In pre-specified analyses of 8,242 patients
followed for at least 3 years, Praluent was associated with a 22%
lower risk of death from any cause (hazard ratio (HR) 0.78; 95% CI,
0.65 to 0.94; nominal p=0.01). Separate post-hoc analyses showed
Praluent-treated patients whose baseline LDL-C levels were at or
above 100 mg/dL experienced a 29% lower risk of death from any
cause (HR 0.71; 95% CI, 0.56 to 0.90).
In additional post-hoc analyses researchers
found Praluent-treated patients experienced fewer non-fatal CV
events and were less likely to die from a non-CV event and that
these two findings may be associated (association between non-fatal
and fatal events = 2.35; 95% CI, 1.98 to 2.73; p<0.0001).
No new safety signals were found in the
analyses. In ODYSSEY OUTCOMES, the incidence of adverse events was
similar in the two groups, with the exception of local
injection-site reactions (3.8% in the Praluent group vs. 2.1% in
the placebo group).
The effect of Praluent on CV morbidity and
mortality is currently being reviewed by regulatory authorities and
has not yet been fully evaluated. Data from the ODYSSEY OUTCOMES
trial have been submitted to regulatory authorities in the European
Union and in the U.S., where the target action date for the Food
and Drug and Administration (FDA) decision is April 28, 2019.
About ODYSSEY OUTCOMES
ODYSSEY OUTCOMES (n=18,924) assessed the effect
of Praluent on the occurrence of major adverse cardiovascular
events (MACE) in patients who had experienced an acute coronary
syndrome (ACS) between 1-12 months (median 2.6 months) 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 a
high-intensity statin.
The trial was designed to maintain patients'
LDL-C levels between 25-50 mg/dL, 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 (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 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 is being developed by Regeneron and Sanofi
under a global collaboration agreement.
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.
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 Ashleigh Koss Tel: +1 (908)
981-8745 ashleigh.koss@sanofi.com |
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Relations Contact George Grofik Tel.: +33 (0)1 53 77 45 45
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Regeneron Media Relations Contact Sarah Cornhill Tel: +1
(914) 847-5018 sarah.cornhill@regeneron.com |
Regeneron Investor
Relations Contact Manisha Narasimhan, Ph.D. Tel: +1 (914)
847-5126 manisha.narasimhan@regeneron.com |
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