TARRYTOWN, N.Y. and PARIS,
June 19, 2020 /PRNewswire/ --
Dupixent included in list of overseas approved drugs that
meet urgent clinical need in China
Dupixent is approved in 60 countries for adults with
moderate-to-severe atopic dermatitis, one of the diseases driven by
type 2 inflammation
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the National Medical Products Administration
(NMPA) in China has approved
Dupixent® (dupilumab) for the treatment of
moderate-to-severe atopic dermatitis in adults whose disease is not
adequately controlled with topical prescription therapies or when
those therapies are not advisable. The NMPA identified Dupixent as
an overseas medicine considered urgently needed in clinical
practice, leading to an expedited review and approval process.
"The limited treatment options in China for moderate-to-severe atopic dermatitis
has left many patients and those who care for them coping with the
physical and emotional burden of the disease," said Professor Zhang
Jianzhong, Chairman of the 13th Session of the Dermatology and
Venereology Branch of the Chinese Medical Association, Director of
Department of Dermatology, Peking University People's Hospital.
"The availability of a targeted treatment like Dupixent provides
hope to those seeking relief from the often unbearable itch and
other symptoms that can significantly impact the lives of adults
living with this chronic disease."
Atopic dermatitis is a chronic inflammatory disease that often
appears as a rash on the skin. Moderate-to-severe atopic dermatitis
is characterized by rashes that can potentially cover much of the
body, and can include intense, persistent itching, skin dryness and
skin lesions including cracking, redness or darkness, crusting and
oozing. Itch is one of the most burdensome symptoms for patients
and can be debilitating. Inadequately controlled atopic dermatitis
can have a physical, emotional and psychosocial impact, causing
sleep disturbance, symptoms of anxiety and depression, and feelings
of isolation.
"As the first biologic medicine approved for moderate-to-severe
atopic dermatitis, Dupixent has transformed the treatment landscape
for patients around the world by targeting the type 2 inflammation
that underlies the disease, rather than broadly suppressing the
immune system," said George D.
Yancopoulos, M.D., Ph.D., Co-founder, President and Chief
Scientific Officer at Regeneron. "More than 150,000 people have
already been treated with Dupixent globally and today's approval
brings this novel treatment to those in China who are in urgent need of new
options."
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins, and is not an immunosuppressant. Data from Dupixent
clinical trials have shown that IL-4 and IL-13 are key drivers of
the type 2 inflammation that plays a major role in atopic
dermatitis, asthma and chronic rhinosinusitis with nasal polyposis
(CRSwNP).
"Sanofi has deep roots in China
and it continues to be a significant area of growth for us. New
regulations have paved the way for first-in-class treatments like
Dupixent to be delivered to patients sooner and, in partnership
with the government's Healthy China 2030 initiative, we plan to
seek approval by 2025 for more than 25 innovative medicines for
chronic and rare diseases and vaccines," said Paul Hudson, Chief Executive Officer at Sanofi.
"The approval of Dupixent in China
offers a new treatment option with an established safety and
efficacy profile. This is a meaningful advance for patients and
their physicians who have struggled to treat the debilitating
symptoms of moderate-to-severe atopic dermatitis which can
seriously impact quality of life."
The approval was based on positive data from the global LIBERTY
AD clinical trial program that included nearly 3,000 patients with
inadequately controlled moderate-to-severe atopic dermatitis. The
trials evaluated Dupixent (monotherapy or in combination with
topical corticosteroids) on safety and efficacy measures, including
skin clearance, overall disease severity and itch. Data from an
ongoing Phase 3 trial in China of
adults with moderate-to-severe atopic dermatitis will be shared
with the NMPA in the second half of 2020 when the trial has
completed.
About Dupixent
Dupixent will be available
in China in a 300 mg dose as a
pre-filled syringe. Dupixent is intended for injection under the
skin (subcutaneous injection) and is given every other week
following an initial loading dose. It can be given in a clinic or
at home by self-administration after training by a healthcare
professional. Dupixent can be used with or without topical
corticosteroids.
Dupixent is currently approved in the U.S., Europe, Japan
and other countries around the world for use in specific patients
with moderate-to-severe atopic dermatitis, as well as certain
patients with asthma or CRSwNP in different age populations.
Dupilumab Development Program
To date, dupilumab has
been studied in more than 10,000 patients across 50 clinical trials
in various chronic diseases driven by type 2 inflammation. In
addition to the currently approved indications, Regeneron and
Sanofi are also studying dupilumab in a broad range of clinical
development programs for diseases driven by allergic and other type
2 inflammation, including pediatric asthma (6 to 11 years of age,
Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 2/3), eosinophilic esophagitis (Phase 3), chronic obstructive
pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo
nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and
food and environmental allergies (Phase 2). These potential uses
are investigational, and the safety and efficacy have not been
evaluated by any regulatory authority. Dupilumab is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
Dupilumab was invented using Regeneron's proprietary
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been used
to create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Ebola virus
infection, which is currently under review by the FDA, and is now
being used in efforts to create prophylactic and treatment
medicines for COVID-19.
U.S. Indications
DUPIXENT is
a prescription medicine used:
- to treat people aged 6 years and older with moderate-to-severe
atopic dermatitis (eczema) that is not well controlled with
prescription therapies used on the skin (topical), or who cannot
use topical therapies. DUPIXENT can be used with or without topical
corticosteroids. It is not known if DUPIXENT is safe and effective
in children with atopic dermatitis under 6 years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
people aged 12 years and older whose asthma is not controlled with
their current asthma medicines. DUPIXENT helps prevent severe
asthma attacks (exacerbations) and can improve your breathing.
DUPIXENT may also help reduce the amount of oral corticosteroids
you need while preventing severe asthma attacks and improving your
breathing. DUPIXENT is not used to treat sudden breathing problems.
It is not known if DUPIXENT is safe and effective in children with
asthma under 12 years of age.
- with other medicines for the maintenance treatment of chronic
rhinosinusitis with nasal polyposis (CRSwNP) in adults whose
disease is not controlled. It is not known if DUPIXENT is safe and
effective in children with chronic rhinosinusitis with nasal
polyposis under 18 years of age.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
Do not use if you are allergic to dupilumab or to
any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the- counter medicines, vitamins
and herbal supplements.
Especially tell your healthcare provider if you are taking oral,
topical, or inhaled corticosteroid medicines; have asthma and use
an asthma medicine; and have atopic dermatitis or CRSwNP, and also
have asthma. Do not change or stop your corticosteroid
medicine or other asthma medicine without talking to your
healthcare provider. This may cause other symptoms that were
controlled by the corticosteroid medicine to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
- Inflammation of your blood vessels. Rarely, this can
happen in people with asthma who receive DUPIXENT. This may happen
in people who also take a steroid medicine by mouth that is being
stopped or the dose is being lowered. It is not known whether this
is caused by DUPIXENT. Tell your healthcare provider right away if
you have: rash, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching, and
cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the throat
(oropharyngeal pain), and high count of a certain white blood cell
(eosinophilia).
- Chronic rhinosinusitis with nasal polyposis: injection
site reactions, eye and eyelid inflammation, including redness,
swelling, and itching, high count of a certain white blood cell
(eosinophilia), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. 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.
Use DUPIXENT exactly as prescribed. Your healthcare provider
will tell you how much DUPIXENT to inject and how often to inject
it. DUPIXENT is an injection given under the skin (subcutaneous
injection). If your healthcare provider decides that you or a
caregiver can give DUPIXENT injections, you or your caregiver
should receive training on the right way to prepare and inject
DUPIXENT. Do not try to inject DUPIXENT until you have been shown
the right way by your healthcare provider. In children 12 years of
age and older, it is recommended that DUPIXENT be administered by
or under supervision of an adult. In children younger than 12 years
of age, DUPIXENT should be given by a caregiver.
Please see full Prescribing Information including
Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN)
is a leading biotechnology company that invents life-transforming
medicines for people with serious diseases. Founded and led for
over 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, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through 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
Regeneron Forward-Looking Statements and Use of Digital
Media
This press 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 expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these
risks and uncertainties include, among others, the impact of
SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on
Regeneron's business and its employees, collaborators, suppliers,
and other third parties on which Regeneron relies, Regeneron's and
its collaborators' ability to continue to conduct research and
clinical programs, Regeneron's ability to manage its supply chain,
net product sales of products marketed by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
global economy; the nature, timing, and possible success and
therapeutic applications of Regeneron's Products and Regeneron's
product candidates and research and clinical programs now underway
or planned, including without limitation Dupixent®
(dupilumab); uncertainty of market acceptance and commercial
success of Regeneron's Products and product candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary) on the commercial success of
Regeneron's Products and product candidates; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's product candidates and new indications for
Regeneron's Products, such as dupilumab for the treatment of
pediatric asthma, pediatric atopic dermatitis, eosinophilic
esophagitis, chronic obstructive pulmonary disease, bullous
pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food
and environmental allergies, and other potential
indications; unforeseen safety issues resulting from the
administration of Regeneron's Products (such as Dupixent) and
product candidates in patients, including serious complications or
side effects in connection with the use of Regeneron's Products and
product candidates in clinical trials; determinations by regulatory
and administrative governmental authorities which may delay or
restrict Regeneron's ability to continue to develop or
commercialize Regeneron's Products (such as Dupixent) and product
candidates; ongoing regulatory obligations and oversight impacting
Regeneron's Products, research and clinical programs, and business,
including those relating to patient privacy; the availability and
extent of reimbursement of Regeneron's Products (such as Dupixent)
from third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
benefit management companies, and government programs such as
Medicare and Medicaid; coverage and reimbursement determinations by
such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to
Regeneron's Products and product candidates; the extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may lead to advancement
of product candidates to clinical trials or therapeutic
applications; the ability of Regeneron to manufacture and manage
supply chains for multiple products and product candidates; the
ability of Regeneron's collaborators, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
finishing, packaging, labeling, distribution, and other steps
related to Regeneron's Products and product candidates;
unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
financial projections or guidance and changes to the assumptions
underlying those projections or guidance; the potential for any
license or collaboration agreement, including Regeneron's
agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), to
be cancelled or terminated without any further product success; and
risks associated with intellectual property of other parties and
pending or future litigation relating thereto (including without
limitation the patent litigation and other related proceedings
relating to Dupixent and Praluent® (alirocumab)),
other litigation and other proceedings and government
investigations relating to the Company and/or its operations, the
ultimate outcome of any such proceedings and investigations, and
the impact any of the foregoing may have on Regeneron's business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the
quarterly period ended March 31,
2020. 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 statements made by
Regeneron. Regeneron does not undertake any obligation to update
publicly any forward-looking statement, including without
limitation any financial projection or guidance, whether as a
result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
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forward-looking statements as defined in the Private Securities
Litigation Reform Act of 1995, as amended. Forward-looking
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statements include projections and estimates regarding the
marketing and other potential of the product, or regarding
potential future revenues from the product. Forward-looking
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similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking
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beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or
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statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
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and development, including future clinical data and analysis of
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and any related future litigation and the ultimate outcome of such
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economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
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Regeneron
Contacts:
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Media
Relations
Hannah
Kwagh
Tel: +1 (914)
847-6314
Hannah.Kwagh@regeneron.com
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Investor
Relations Mark
Hudson Tel.: +1 (914) 847
3482 Mark.Hudson@regeneron.com
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Sanofi Contacts:
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Media
Relations
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Tel.: +1 (732)
532-5318
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Lauscher
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.