BRIDGEWATER, N.J. and
TARRYTOWN, N.Y., Sept. 12, 2018 FDA also recently approved
Praluent label update for some patients currently requiring LDL
apheresis therapy
/PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc.
announced that the U.S. Food and Drug Administration (FDA) has
accepted a supplemental Biologics License Application (sBLA) for
Praluent® (alirocumab) Injection, a PCSK9 inhibitor. The sBLA
outlines a proposed update to the Prescribing Information to
include the effect of Praluent in reducing the overall risk of
major adverse cardiovascular events (MACE). MACE is an umbrella
term that includes heart attack, ischemic stroke, death from
coronary heart disease and unstable angina requiring
hospitalization. The FDA set a Prescription Drug User Fee Act
(PDUFA) action date of April 28,
2019.
The sBLA is supported by data from ODYSSEY OUTCOMES, a Phase 3
cardiovascular outcomes trial that assessed the effect of Praluent
in 18,924 patients who had an acute coronary syndrome (ACS), such
as a heart attack, between 1-12 months (median 2.6 months) before
enrolling in the trial. Results of the ODYSSEY OUTCOMES trial were
presented at the American College of Cardiology's 67th
Annual Scientific Session & Expo in March 2018.
The effect of Praluent on cardiovascular morbidity and
mortality, including MACE, is currently being reviewed and has not
been fully evaluated by any regulatory authority.
Additional Treatment Option for Patients Who Currently
Require Apheresis Therapy
In addition, the FDA recently approved an update to the Praluent
Prescribing Information to include clinical information regarding
its use in patients with heterozygous familial hypercholesterolemia
(HeFH) who require additional lowering of LDL-C (low-density
lipoprotein cholesterol) along with diet and maximally-tolerated
statin therapy and who are undergoing apheresis treatment.
Apheresis is a procedure where LDL-C is removed from the blood, in
a process similar to kidney dialysis. The recommended dose of
Praluent in patients undergoing LDL apheresis is 150 mg once every
2 weeks. Praluent can be administered without regard to timing of
apheresis.
The update is supported by data from the pivotal Phase 3 ODYSSEY
ESCAPE trial of 62 patients with HeFH, an inherited form of high
cholesterol, whose cholesterol levels required chronic, weekly or
bi-weekly apheresis therapy.
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
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 diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, 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 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
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
Sanofi Media
Relations Contact
|
Sanofi Investor
Relations Contact
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George
Grofik
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Tel: +1 (908)
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45 45
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ashleigh.koss@sanofi.com
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ir@sanofi.com
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Regeneron Media
Relations Contact
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Regeneron Investor
Relations Contact
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Manisha Narasimhan,
Ph.D.
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Tel: +1 (917)
297-1522
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Tel: +1 (914)
847-5126
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sarah.cornhill@regeneron.com
|
manisha.narasimhan@regeneron.com
|
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may differ materially from these forward-looking statements.
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now underway or planned, including without limitation
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SOURCE Sanofi