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
Praluent
Praluent® (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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includes forward-looking statements that involve risks and
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