- ODYSSEY OUTCOMES trial met its primary endpoint, demonstrating
that high-risk patients who added Praluent® (alirocumab)
to maximally-tolerated statins experienced significantly fewer
major adverse cardiovascular events compared to those on
maximally-tolerated statins alone
- For the first time, adding a lipid-lowering therapy to
maximally-tolerated statins was associated with reduced death from
any cause
- More pronounced effect observed in patients with baseline LDL-C
levels at or above despite maximally-tolerated statins, who are at
high risk of suffering a future event; in this group, Praluent
reduced risk of major adverse cardiovascular events by 24% and was
associated with a 29% lower risk of death overall
- In this 18,924-patient, long-term trial, the safety profile of
Praluent was consistent with previous trials and no new safety
issues were observed
LAVAL, QC, March 10, 2018 /CNW Telbec/ - Sanofi and
Regeneron Pharmaceuticals, Inc. today announced that the ODYSSEY
OUTCOMES trial met its primary endpoint, showing
Praluent® (alirocumab) significantly reduced the risk of
major adverse cardiovascular events (MACE) in patients who had
suffered a recent acute coronary syndrome (ACS) event such as a
heart attack. Results from the trial was presented today during a
late-breaker session at the American College of Cardiology's
67th Annual Scientific Session (ACC.18) in Orlando, Florida and are available here.
Key findings include:
- On the primary endpoint, Praluent reduced the overall risk of
MACE by 15% (HR=0.85, CI: 0.78-0.93, p=0.0003). The MACE composite
endpoint includes patients who experienced a heart attack, ischemic
stroke, death from coronary heart disease (CHD), or unstable angina
requiring hospitalization.
- Praluent was also associated with a lower risk of death
overall, known as "all-cause mortality" (HR=0.85; CI: 0.73-0.98,
nominal p=0.026), and there were also numerically fewer CHD deaths
(HR=0.92; CI: 0.76-1.11, p=0.38).
- In a pre-specified analysis, the patients with baseline LDL-C
levels at or above 100 mg/dL (2.6 mmol/L) experienced a more
pronounced effect from Praluent, reducing their risk of MACE by 24%
(HR=0.76, CI: 0.65-0.87). In a post-hoc analysis of this group,
Praluent was associated with a lower risk of death from any cause
by 29% (HR=0.71, CI: 0.56-0.90).
- The analyses described above include the results from 730
patients (8%) in the Praluent group who continued to be assessed in
the Praluent arm despite stopping active Praluent therapy, as
specified in the protocol for patients with persistent LDL-C
readings below 15 mg/dL.
- For those in the Praluent treatment arm, approximately 75% of
patient time was on the 75 mg dose.
- There were no new safety signals in the trial, with injection
site reactions experienced more commonly in the Praluent group
compared to patients on maximally-tolerated statins alone (3.8%
Praluent; 2.1% placebo). There was no difference in neurocognitive
events (1.5% Praluent; 1.8% placebo) or new-onset diabetes (9.6%
Praluent; 10.1% placebo).
"This trial was consistent with earlier statin trials, showing
the greatest benefit in patients with higher cholesterol levels at
baseline," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer, Regeneron. "Many patients who have survived a recent heart
attack or other coronary event are unable to reach an LDL
cholesterol goal of less than 100 mg/dL, and have an urgent need
for new therapeutic options because of their increased risk of
another event. In this trial, such patients who received Praluent
on top of maximally-tolerated statins had important reductions in
their risk."
"Not all patients with heart disease are the same.
Through this trial, we have been able to identify high-risk
patients treated with optimal statins who still have an urgent need
for additional treatment options," said Elias Zerhouni, M.D., President, Global R&D,
Sanofi. "With nearly 90 percent of the patients in this trial on
high-intensity statins, the data demonstrate that a
precision-medicine approach in the field of cardiovascular disease
may further advance how we better treat high-risk patients."
"The results of this study, the only one specifically
designed to evaluate the long-term clinical benefit of Praluent
initiation with patients post acute coronary syndrome, demonstrate
the value that Praluent can bring to the health of those who are
unable to reach their LDL-C health goals," claimed Niven Al-Khoury, President, Sanofi Canada. "With
over 60 years of experience working to understand and support the
healthcare needs of patients, bringing valuable solutions is core
to our purpose."
About ODYSSEY OUTCOMES
ODYSSEY OUTCOMES (n=18,924)
assessed the effect of Praluent on the occurrence of MACE in
patients who had experienced an ACS between 1-12 months (median 2.6
months) before enrolling in the trial, and who were already on
maximally-tolerated statins. All patients were randomized to
receive Praluent (n=9,462) or a placebo (n=9,462) and were treated
for an average (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 (0.6 -1.3 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 (1.3 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 (0.6 mmol/L) (n=805), and
patients who experienced two consecutive LDL-C measurements below
15 mg/dL (0.4 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, which lowers LDL-C levels in the blood. The
use of Praluent to reduce the risk of MACE is investigational and
has not been evaluated by any regulatory agency.
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).
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 effect of Praluent on cardiovascular morbidity and mortality
has not been determined.
For the product monograph:
http://products.sanofi.ca/en/praluent.pdf
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 entities in Canada
employ close to 1,900 people. In 2016 we invested $130 million in R&D in Canada, creating jobs, business and
opportunity throughout the country.
Follow us on Twitter @SanofiCanada and on YouTube.
Sanofi, Empowering Life
SOURCE SANOFI