TARRYTOWN, N.Y. and
PARIS, Dec.
8, 2021 /PRNewswire/ --
Dupixent significantly reduced severe asthma attacks and
improved lung function and asthma control in children aged 6 to 11
years with uncontrolled moderate-to-severe asthma
Published results reinforce well-established safety profile
of Dupixent
Positive data formed the basis for FDA approval of Dupixent
in these patients with certain types of moderate-to-severe asthma
and regulatory reviews are ongoing in the European Union
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the New England Journal of Medicine has
published positive results from a pivotal Dupixent®
(dupilumab) clinical trial in children aged 6 to 11 years with
uncontrolled moderate-to-severe asthma. These data formed the basis
for the FDA approval of Dupixent on October 20, 2021 as an add-on maintenance
treatment of patients aged 6 to 11 years with moderate-to-severe
asthma characterized by an eosinophilic phenotype or with oral
corticosteroid-dependent asthma.
These published results showed Dupixent, when added to standard
of care, significantly reduced severe asthma attacks and, within
two weeks, rapidly improved lung function in populations with an
eosinophilic phenotype, as indicated by elevated blood eosinophils,
a certain type of white blood cell, and/or with elevated fractional
exhaled nitric oxide (FeNO), an airway biomarker of inflammation
that plays a major role in asthma.
"The publication of these Phase 3 results for Dupixent in the
New England Journal of Medicine underscore their
significance and potential clinical value for younger children with
uncontrolled moderate-to-severe asthma," said Leonard B. Bacharier, M.D., Professor of
Pediatrics and Director of the Center for Pediatric Asthma
Research, Monroe Carell Jr.
Children's Hospital at Vanderbilt
University Medical Center in Nashville, Tennessee, and principal
investigator of the trial. "These data also further our
understanding of how addressing type 2 inflammation, a biological
process that underlies most cases of childhood asthma, can
potentially improve symptoms and outcomes for children suffering
from this common chronic disease."
Asthma is one of the most common chronic diseases in children.
Approximately 75,000 children aged 6 to 11 years live with the
uncontrolled moderate-to-severe form of the disease in the U.S.,
and many more worldwide. Despite treatment with current
standard-of-care inhaled corticosteroids and bronchodilators, these
children may continue to experience serious symptoms such as
coughing, wheezing and difficulty breathing. They also may require
multiple courses of systemic corticosteroids that can carry
significant safety risks.
The safety results from the trial were generally consistent with
the known safety profile of Dupixent in patients aged 12 years and
older with uncontrolled moderate-to-severe asthma, with the
addition of helminth infections that were reported in 2.2% of
Dupixent patients and 0.7% of placebo patients. The overall rates
of adverse events were 83% for Dupixent and 80% for placebo. The
most common adverse events that were more commonly observed with
Dupixent compared to placebo were injection site reactions (18%
Dupixent, 13% placebo), viral upper respiratory tract infections
(12% Dupixent, 10% placebo) and eosinophilia (6% Dupixent, 1%
placebo).
Dupixent, which was invented using Regeneron's proprietary
VelocImmune® technology, 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. IL-4 and IL-13 are key and central drivers of
the type 2 inflammation that plays a major role in atopic
dermatitis, asthma and chronic rhinosinusitis with nasal polyposis
(CRSwNP).
The results of this Phase 3 trial were also included in the
European regulatory filing, and a decision from the European
Medicines Agency in children with uncontrolled severe asthma is
expected in Q1 2022.
About the LIBERTY ASTHMA VOYAGE Trial
The Phase 3
randomized, double-blind, placebo-controlled trial evaluated the
efficacy and safety of Dupixent (100 mg for children ≤30 kg or 200
mg for children >30 kg every two weeks) combined with
standard-of-care asthma therapy in 408 children aged 6 to 11 years
with uncontrolled moderate-to-severe asthma. The primary endpoint
was the annualized rate of severe asthma exacerbations over one
year and the key secondary endpoint was the change from baseline in
percentage of predicted pre-bronchodilator FEV1
(ppFEV1) at week 12.
About Dupixent
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. Dupixent is also approved in one or more of these
indications in more than 60 countries around the world and more
than 300,000 patients have been treated globally.
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
Regeneron's
VelocImmune technology utilizes a proprietary genetically
engineered mouse platform endowed with a genetically humanized
immune system to produce optimized fully human antibodies. When
Regeneron's 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
approximately a quarter of all original, FDA-approved or authorized
fully human monoclonal antibodies currently available. This
includes Dupixent, REGEN-COV® (casirivimab and
imdevimab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and InmazebTM
(atoltivimab, maftivimab, and odesivimab-ebgn).
Dupilumab Development Program
Dupilumab is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. To date, dupilumab has been studied across
60 clinical trials involving more than 10,000 patients with various
chronic diseases driven in part 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
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), allergic
bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase
2). These potential uses of dupilumab are currently under clinical
investigation, and the safety and efficacy in these conditions have
not been fully evaluated by any regulatory authority.
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 6 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 6 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.
-
- A pregnancy registry for women who take DUPIXENT during
pregnancy collects information about the health of you and your
baby. To enroll or get more information 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), high count of a certain white blood cell
(eosinophilia), and parasitic (helminth) infections.
- 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, hematologic
conditions, 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.
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
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employees, collaborators, and suppliers and other third parties on
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and the global economy; the nature, timing, and possible success
and therapeutic applications of Regeneron's Products and product
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without limitation Dupixent® (dupilumab) for the
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any of the foregoing or any potential regulatory approval of
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treatment of chronic obstructive pulmonary disease with evidence of
type 2 inflammation, pediatric atopic dermatitis, eosinophilic
esophagitis, bullous pemphigoid, prurigo nodularis, chronic
spontaneous urticaria, chronic inducible urticaria-cold, chronic
rhinosinusitis without nasal polyposis, allergic fungal
rhinosinusitis, allergic bronchopulmonary aspergillosis, peanut
allergy, and other potential indications; the ability of
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complications or side effects in connection with the use of
Regeneron's Products and Regeneron's Product Candidates in clinical
trials; determinations by regulatory and administrative
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ability to continue to develop or commercialize Regeneron's
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limitation Dupixent; ongoing regulatory obligations and oversight
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research and development programs conducted by Regeneron and/or its
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and/or lead to advancement of product candidates to clinical
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be cancelled or terminated; and risks associated with intellectual
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thereto (including without limitation the patent litigation and
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(aflibercept) Injection, Dupixent, Praluent®
(alirocumab), and REGEN-COV® (casirivimab and
imdevimab)), other litigation and other proceedings and government
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quarterly period ended September 30,
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Regeneron
Contacts:
Media
Relations
Sharon
Chen
Tel: +1
914-847-1546
sharon.chen@regeneron.com
|
Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443
Vesna.Tosic@regeneron.com
|
Sanofi
Contacts:
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Relations
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Bain
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781-264-1091
Sally.Bain@sanofi.com
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Investor
Relations
Sanofi Investor
Relations – Contacts Paris
Eva
Schaefer-Jansen
Arnaud
Delepine
Nathalie
Pham
Sanofi Investor
Relations – Contact North America
Felix
Lauscher
Sanofi IR main
line:
Tel: +33 (0)1 53 77
45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
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