TARRYTOWN, N.Y. and
PARIS, March 4, 2021 /PRNewswire/ --
Submission supported by data demonstrating Dupixent
significantly reduced severe asthma attacks and is the only
biologic to improve lung function in children aged 6 to 11 years in
a randomized Phase 3 trial
Dupixent has the potential to be a best-in-class treatment
option in this younger population of children aged 6 to 11
Acceptance represents another milestone in the development of
Dupixent in addressing diseases driven by type 2
inflammation
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the supplemental Biologics License Application
(sBLA) for Dupixent® (dupilumab) as an add-on treatment
for children aged 6 to 11 years with uncontrolled
moderate-to-severe asthma. Dupixent is currently approved as an
add-on treatment for patients with uncontrolled moderate-to-severe
asthma aged 12 and older with elevated eosinophils or oral
corticosteroid dependent asthma. The target action date for the FDA
decision is October 21, 2021 and the
European Union (EU) regulatory submission for children aged 6 to 11
years with asthma is planned for Q1 2021.
In the U.S., there are approximately 75,000 children aged 6 to
11 years with uncontrolled moderate-to-severe asthma, which can
carry a significant burden for children and their families. Despite
treatment with current standard-of-care inhaled corticosteroids and
bronchodilators, these children can still experience coughing,
wheezing, and difficulty breathing. They are also at risk for
life-threatening severe asthma attacks that can lead to
hospitalization and emergency room visits, and may require the use
of systemic corticosteroids which carry significant risks when used
long term. Uncontrolled moderate-to-severe asthma can impair lung
function, and can interfere with day-to-day activities, like
sleeping, attending school and playing sports.
The sBLA is supported by data that include pivotal Phase 3
results evaluating the efficacy and safety of Dupixent in addition
to standard-of-care maintenance therapy in children with
moderate-to-severe asthma with type 2 inflammation, characterized
by raised blood eosinophil levels and/or raised fractional exhaled
nitric oxide (FeNO) levels. In the trial, Dupixent significantly
reduced severe asthma attacks and rapidly improved lung function
within two weeks in children aged 6 to 11 years. Safety results
were generally consistent with the well-established safety profile
of Dupixent in the approved indication for patients aged 12 and
older with moderate-to-severe asthma. Adverse events in the Phase 3
trial that were more commonly observed with Dupixent included
injection site reactions, viral upper respiratory tract infections
and eosinophilia. Detailed results from this Phase 3 trial will be
published later this year.
Dupixent is a fully human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
pathways and is not an immunosuppressant. It was invented using
Regeneron's proprietary VelocImmune® technology.
IL-4 and IL-13 are key and central drivers of the type 2
inflammation that plays a major role in asthma, chronic
rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and
eosinophilic esophagitis.
About Dupixent
Dupixent is approved in
the U.S. to treat patients aged 6 years and older with
moderate-to-severe atopic dermatitis that is not well controlled
with prescription therapies used on the skin (topical), or who
cannot use topical therapies; for use with other asthma medicines
for the maintenance treatment of moderate-to-severe eosinophilic or
oral steroid dependent asthma in patients aged 12 years and older
whose asthma is not controlled with their current asthma medicines;
and for use with other medicines for the maintenance treatment of
CRSwNP in adults whose disease is not controlled.
Outside of the U.S., Dupixent is approved for specific
patients with moderate-to-severe atopic dermatitis and certain
patients with asthma in a number of other countries around the
world, including those in the EU and Japan. Dupixent is also
approved in the EU and Japan to treat certain adults with
severe CRSwNP. Across all approved indications globally, more than
200,000 patients have been treated with Dupixent.
Dupixent is intended for use under the guidance of a healthcare
professional and can be given in a clinic or at home by
self-administration after training by a healthcare professional. In
children younger than 12 years of age, Dupixent should be
administered by a caregiver.
About Regeneron's VelocImmune®
Technology
Dupixent was invented using Regeneron's
VelocImmune technology that utilizes a proprietary
genetically engineered mouse platform endowed with a genetically
humanized immune system to produce optimized fully human
antibodies. When Regeneron's co-Founder, President and Chief
Scientific Officer George D.
Yancopoulos was a graduate student with his mentor
Frederick W. Alt in 1985, they were
the first to envision making such a genetically humanized
mouse, and Regeneron has spent decades inventing and
developing VelocImmune and
related VelociSuite® technologies. Dr.
Yancopoulos and his team have used VelocImmune technology to
create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab),
Kevzara® (sarilumab), Evkeeza™
(evinacumab-dgnb), Inmazeb™ (atoltivimab, maftivimab,
and odesivimab-ebgn).
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 studying dupilumab in a broad range of diseases driven
by type 2 inflammation or other allergic processes, including
pediatric asthma (6 to 11 years of age, Phase 3), chronic
obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid
(Phase 3), prurigo nodularis (Phase 3), chronic spontaneous
urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3),
chronic rhinosinusitis without nasal polyposis (Phase 3), allergic
fungal rhinosinusitis (Phase 3) and food allergies (Phase 2). These
potential uses are under clinical investigation, and the safety and
efficacy of dupilumab in these conditions have not been fully
evaluated by any regulatory authority. Dupilumab is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
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.
- o There is a pregnancy exposure registry for women who take
DUPIXENT during pregnancy to collect information about the health
of you and your baby. Your healthcare provider can enroll you or
you may enroll yourself. To get more information about the registry
call 1–877-311-8972 or go to
https://mothertobaby.org/ongoing-study/dupixent/.
- 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; or 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 or other asthma 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 by indication are as
follows:
- 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 accompanying 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 nine
FDA-approved treatments and numerous product candidates in
development, almost 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
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"estimate," variations of such words, and similar expressions are
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possible success and therapeutic applications of Regeneron's
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and research and clinical programs now underway or planned,
including without limitation Dupixent® (dupilumab) as an
add-on treatment for children aged 6 to 11 years with uncontrolled
moderate-to-severe asthma characterized by raised blood eosinophil
levels and/or raised fractional exhaled nitric oxide (FeNO) levels
("Pediatric Asthma"); 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, chronic
obstructive pulmonary disease, pediatric atopic dermatitis,
eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis,
chronic spontaneous urticaria, food and environmental allergies,
and other potential indications; uncertainty of market
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coverage and reimbursement determinations by such payers and new
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extent to which the results from the research and development
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the ability of Regeneron's collaborators, suppliers, or other third
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Ltd. (or their respective affiliated companies, as applicable), to
be cancelled or terminated; 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 EYLEA®
(aflibercept) Injection, Dupixent, Praluent®
(alirocumab), and REGEN-COV™ (casirivimab and
imdevimab)), 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
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in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2020. Any forward-looking
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Regeneron uses its media and investor relations website and
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Regeneron
Contacts:
Media
Relations
Sharon
Chen
Tel:
+1 914-847-1546
Sharon.Chen@regeneron.com
|
Investor
Relations
Mark
Hudson
Tel: +1
914-847-3482
Mark.Hudson@regeneron.com
|
|
|
Sanofi
Contacts:
Media
Relations
Sally
Bain
Tel: +1
781-264-1091
Sally.Bain@sanofi.com
|
Investor
Relations
Sanofi Investor
Relations – Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Yvonne Naughton
Sanofi Investor
Relations – Contacts North America Felix Lauscher Fara Berkowitz Suzanne Greco
Sanofi IR main
line: Tel: +33 (0)1 53 77
45 45
ir@sanofi.com https://www.sanofi.com/en/investors/contact
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SOURCE Regeneron Pharmaceuticals, Inc.