FDA approves Praluent® (alirocumab) to prevent heart attack,
stroke and unstable angina requiring hospitalization
- Praluent is the first PCSK9 inhibitor that has shown a
meaningful reduction in death from any cause
- Praluent treatment effect was observed in patients already
receiving other lipid-lowering therapies, including
maximally-tolerated statins
PARIS and TARRYTOWN, NY - April 26, 2019
- The U.S. Food and Drug Administration (FDA) has approved
Praluent® (alirocumab) to reduce the risk of heart attack, stroke,
and unstable angina requiring hospitalization in adults with
established cardiovascular (CV) disease.
"Today's FDA approval marks a significant
achievement in the treatment of adults with established
cardiovascular disease, who are among those at greatest risk of
death or disability caused by serious cardiovascular events," said
John Reed, M.D., Ph.D., Global Head of Research & Development,
Sanofi. "Praluent has already helped many adults lower their LDL-C
levels, and this new indication provides an opportunity to help
appropriate patients by reducing the risk of serious,
life-threatening cardiovascular events, including heart attacks and
stroke."
High levels of "bad" cholesterol, also known as
low-density lipoprotein cholesterol (LDL-C), increase patients'
risk for serious CV events such as heart attack or stroke. Adults
who experience a heart attack or stroke have an approximately one
in three chance to have another CV event.
"Heart disease accounts for one quarter of all American deaths
each year and many others are at risk for heart attack and stroke
due to uncontrolled LDL-C levels," said George D. Yancopoulos,
M.D., Ph.D., President and Chief Scientific Officer, Regeneron.
"The Phase 3 ODYSSEY OUTCOMES trial showed that people who received
Praluent significantly reduced their risk for serious
cardiovascular events. There was also a clinically-meaningful
reduction in death from any cause with Praluent treatment. With
this approval, and the recent introduction of a lower U.S. Praluent
list price, we hope that more patients in need will be able to
access Praluent."
The FDA approval is based on data from ODYSSEY
OUTCOMES, which was published in the New England Journal of
Medicine in November 2018, assessing the effect of adding Praluent
to maximally-tolerated statins on CV outcomes in 18,924 patients
who had an acute coronary syndrome (ACS) within a year of enrolling
in the trial. Patients who received Praluent in the trial
experienced:
- A 15% reduced risk for major CV events. The primary endpoint
included time to first heart attack, stroke, death from coronary
heart disease (CHD), or unstable angina requiring hospitalization
(HR 0.85; 95% CI, 0.78 to 0.93; p=0.0003).
- A 27% reduced risk of stroke, 14% reduced risk of non-fatal
heart attack and 39% reduced risk of unstable angina requiring
hospitalization.*
- A 15% reduced risk of death from any cause (also called
all-cause mortality; HR 0.85; 95% CI, 0.73 to 0.98; nominal
p=0.026) was also observed.*
*Because statistical testing of these endpoints was performed
outside of the hierarchy, the results are not considered
statistically significant.
Adverse events were similar between the Praluent
and placebo groups, except for injection site reactions (Praluent
3.8%, placebo 2.1%). In ODYSSEY OUTCOMES, the adverse events that
occurred in >5% of patients included: non-cardiac chest pain
(7.0% Praluent, 6.8% placebo), nasopharyngitis (6.0% Praluent, 5.6%
placebo) and myalgia (5.6% Praluent, 5.3% placebo).
Expanded Indication to Include Patients with
Other Types of High LDL-C The FDA also approved Praluent as an
adjunct to diet, alone or in combination with other lipid-lowering
therapies (e.g., statins, ezetimibe), for the treatment of adults
with primary hyperlipidemia (including heterozygous familial
hypercholesterolemia) to reduce LDL-C.
Praluent was the first PCSK9 (proprotein
convertase subtilisin/kexin type 9) inhibitor approved by the FDA
and is the only PCSK9 inhibitor available in two doses with two
levels of efficacy as a single 1 mL injection (75 mg and 150 mg)
once every two weeks. It can also be administered as 300 mg once
every four weeks (monthly), enabling physicians to tailor treatment
based on an individual patient's LDL-C-lowering needs.
About ODYSSEY OUTCOMES ODYSSEY OUTCOMES,
the longest CV outcomes trial of any PCSK9 inhibitor to date,
assessed the effect of Praluent on the occurrence of major adverse
CV events 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 five years. Approximately 90% of patients were on high-intensity
statins prior to randomization.
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 two weeks and switched to
150 mg every two 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
(0.39 mmol/L) while on the 75 mg dose (n=730) stopped active
Praluent therapy for the remainder of the trial.
About PraluentPraluent® (alirocumab)
inhibits the binding of PCSK9 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 U.S., European Union (EU), Japan, Canada,
Switzerland, Mexico and Brazil. In the U.S., Praluent is approved
to reduce the risk of heart attack, stroke and unstable angina
requiring hospitalization. Praluent is also approved as an adjunct
to diet, alone or in combination with other lipid lowering
therapies (e.g., statins, ezetimibe), for the treatment of adults
with primary hyperlipidemia (including heterozygous familial
hypercholesterolemia) to reduce LDL-C.
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 Joe Ricculli Tel: +1 (914) 847-0405
joseph.ricculli@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 |
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