TARRYTOWN, N.Y. and
PARIS, July
5, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that the Ministry of
Health, Labor and Welfare in Japan
has granted marketing and manufacturing authorization for
Praluent® (alirocumab) for the treatment of uncontrolled
low-density lipoprotein (LDL) cholesterol, in certain adult
patients with hypercholesterolemia at high cardiovascular risk.
Praluent is a human monoclonal antibody targeting PCSK9
(proprotein convertase subtilisin/kexin type 9). In Japan, Praluent is indicated for the treatment
of patients with hypercholesterolemia and familial
hypercholesterolemia (FH) who are at high cardiovascular risk and
in whom treatment with statins (HMG-CoA reductase inhibitors) is
not sufficient. Praluent 75 mg and 150 mg will be available in
Japan as a single-dose pre-filled
pen and syringe.
"Hypercholesterolemia is a significant concern in Japan, and many patients are not able to
achieve their LDL cholesterol treatment goals despite current
lipid-lowering therapy," said Jay
Edelberg, MD, Ph.D., Head of Cardiovascular Development,
Sanofi. "For these patients, Praluent could be an important
treatment option to help address their needs."
Data from the global Phase 3 ODYSSEY trials showed consistent,
robust reductions in LDL cholesterol for Praluent compared to
placebo, when added to current standard-of-care, which included
maximally-tolerated statins. The Phase 3 ODYSSEY JAPAN trial evaluated the safety and efficacy
of Praluent 75 mg starting dose every two weeks, in comparison with
placebo in 216 Japanese patients with primary hypercholesterolemia
and LDL cholesterol of at least 100 milligrams/deciliter (mg/dL)
(at least 2.59 millimoles per liter [mmol/L]). All study patients
were on ongoing statin treatment with or without other
lipid-lowering therapies. Average baseline LDL cholesterol levels
in the randomized population were similar between the Praluent (141
mg/dL / 3.6 mmol/L) and placebo groups (142 mg/dL / 3.7
mmol/L). Patients in the Praluent group who did not achieve
their pre-specified LDL cholesterol goals with Praluent 75 mg at
week 8 (2 out of 140 patients who continued treatment beyond week
12) were increased to Praluent 150 mg every two weeks at week
12.
In the ODYSSEY JAPAN trial,
Praluent reduced LDL cholesterol by 63 percent at week 24 on top of
stable background statin therapy, compared to a 2 percent increase
in the placebo group (p less than 0.0001, ITT analysis). Patients
treated with Praluent maintained their LDL cholesterol reductions
for the duration of the trial. By week 52, patients in the Praluent
group achieved an average LDL cholesterol of 53.4 mg/dL (1.38
mmol/L) compared to an average LDL cholesterol of 135.6 mg/dL (3.51
mmol/L) in the placebo group (ITT population).
In the trial, Praluent was generally well-tolerated with an
acceptable safety profile. Frequently reported adverse events
included nasopharyngitis (46 percent Praluent versus 36 percent
placebo); back pain (13 percent Praluent versus 6 percent placebo);
and injection site reaction (13 percent Praluent versus 4 percent
placebo).
"Results from the Japanese Phase 3 trial were consistent with
the findings from our global ODYSSEY program that evaluated the
efficacy and safety of Praluent in patients who required further
reduction of their LDL cholesterol," said Bill Sasiela, Ph.D., VP, Program Direction,
Regeneron. "Notably, in the ODYSSEY JAPAN trial, 99 percent of patients were able
to effectively reach their LDL cholesterol goals as defined by the
Japan Atherosclerosis Society with Praluent 75 mg Q2W and maintain
these reductions for the duration of their therapy, up to 52
weeks."
In ODYSSEY JAPAN, LDL
cholesterol goals were defined according to the "Guidelines for
Prevention of Atherosclerotic Cardiovascular Diseases 2012"
published by the Japan Atherosclerosis Society (JAS) in which goals
are set according to patients' risk of cardiovascular events. The
JAS guidelines define the risk of cardiovascular events as high
when the patient has a history of coronary artery disease, a
history of ischemic stroke (other than cardiogenic cerebral
infarction), peripheral artery disease, diabetes mellitus, and
chronic kidney disease, or in the presence of several risk factors
for atherosclerosis.
In Japanese Phase 2 and 3 clinical trials, adverse events were
observed in 17 percent (33 of 193) of patients on Praluent 75 mg or
150 mg. The most common adverse event was injection site reactions
in 22 cases (11.4 percent).
Praluent is also approved in the
United States, European Union,
Canada and Mexico. The
effect of Praluent on cardiovascular morbidity and mortality has
not yet been determined.
About Praluent
Praluent inhibits the binding of PCSK9
to the LDL receptor and thereby increases the number of available
LDL receptors on the surface of liver cells, which results in lower
LDL cholesterol (so-called "bad" cholesterol) levels in the
blood.
In July 2015, the companies
announced that Praluent was approved for use in the U.S. as adjunct
to diet and maximally tolerated statin therapy for the treatment of
adults with HeFH or clinical atherosclerotic cardiovascular
disease, who require additional lowering of LDL cholesterol.
In September 2015, the European
Commission approved the marketing authorization for Praluent. In
the E.U., Praluent is approved for the treatment of adult patients
with primary hypercholesterolemia (HeFH and non-familial) or mixed
dyslipidemia as an adjunct to diet: a) in combination with a
statin, or statin with other lipid-lowering therapies in patients
unable to reach their LDL cholesterol goals with the
maximally-tolerated statin or b) alone or in combination
with other lipid-lowering therapies for patients who are statin
intolerant, or for whom a statin is contraindicated.
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.
Important Japan Product Information
Praluent is
indicated for the treatment of patients with FH or
hypercholesterolemia who have high cardiovascular risk with LDL
cholesterol not adequately controlled by HMG-CoA reductase
inhibitors.
Precautions Related to Indications in Japan
(1) Patients should undergo
careful medical examinations, including tests confirming FH or
non-FH before using Praluent.
(2) In patients with non-FH, the use of Praluent should be
considered for patients with high cardiovascular risk based on
confirmed risk factors (e.g., coronary artery disease,
non-cardiogenic cerebral infarction, peripheral arterial disease,
diabetes mellitus, chronic kidney disease, etc.) See 'Clinical
Studies' section.
(3) For homozygous FH, the efficacy and safety of Praluent
has not been established. Treatment with Praluent should be
carefully determined, and in case of no response, treatment should
be discontinued. See 'Important Precautions (2)' section.
Dosage and Administration in Japan
For adults, the usual dosage is
75 mg administered subcutaneously every two weeks. If there is an
insufficient response, dosage can be increased to 150 mg.
Precautions Related to Dosage and Administration in
Japan
(1) Praluent
should be administered in combination with HMG-CoA reductase
inhibitor therapy. (The efficacy and safety of Praluent monotherapy
in Japanese patients has not been established.)
(2) When used with LDL apheresis treatment concomitantly,
Praluent treatment should be scheduled following the LDL apheresis
treatment.
Important Safety Information for 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 Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is
listed in Paris (EURONEXT: SAN)
and in New York (NYSE: SNY).
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading science-based biopharmaceutical company
based in Tarrytown, New York that
discovers, invents, develops, manufactures and commercializes
medicines for the treatment of serious medical conditions.
Regeneron commercializes medicines for eye diseases, high
LDL-cholesterol, and a rare inflammatory condition and has product
candidates in development in other areas of high unmet medical
need, including rheumatoid arthritis, asthma, atopic dermatitis,
pain, cancer and infectious diseases. For additional information
about the company, please visit www.regeneron.com or follow
@Regeneron on Twitter.
Sanofi Forward-Looking Statements
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release contains forward-looking statements as defined in the
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Forward-looking statements are statements that are not historical
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regarding whether and when to approve any drug, device or
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Regeneron Forward-Looking Statements and Use of Digital
Media
This news release includes forward-looking
statements that involve risks and uncertainties relating to future
events and the future performance of Regeneron Pharmaceuticals,
Inc. ("Regeneron" or the "Company"), and actual events or results
may differ materially from these forward-looking statements. Words
such as "anticipate," "expect," "intend," "plan," "believe,"
"seek," "estimate," variations of such words, and similar
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these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of Regeneron's
products, product candidates, and research and clinical programs
now underway or planned, including without limitation
Praluent® (alirocumab) Injection; unforeseen safety
issues and possible liability resulting from the administration of
products (including without limitation Praluent) and product
candidates in patients; serious complications or side effects in
connection with the use of Regeneron's products and product
candidates in clinical trials, such as the ODYSSEY OUTCOMES trial
prospectively assessing the potential of Praluent to demonstrate
cardiovascular benefit; coverage and reimbursement determinations
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benefit management companies; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products (such as
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those relating to the enrollment, completion, and meeting of the
relevant endpoints of post-approval studies (such as the ODYSSEY
OUTCOMES trial); determinations by regulatory and administrative
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companies, as applicable), to be cancelled or terminated without
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property of other parties and pending or future litigation relating
thereto. A more complete description of these and other material
risks can be found in Regeneron's filings with the United States
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2015 and its
Form 10-Q for the quarterly period ended March 31, 2016. Any forward-looking statements
are made based on management's current beliefs and judgment, and
the reader is cautioned not to rely on any forward-looking
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including without limitation any financial projection or guidance,
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Contacts
Sanofi:
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Relations
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Tel: +33 (0)1 53 77
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mr@sanofi.com
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Relations
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45 45
ir@sanofi.com
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Contacts
Regeneron:
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Arleen
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847-3456
Mobile: +1 (914)
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Relations
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Narasimhan, Ph.D.
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847-5126
manisha.narasimhan@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.