TARRYTOWN, N.Y. and
PARIS, Oct.
20, 2021 /PRNewswire/ --
Dupixent is the only biologic medicine to improve lung
function in children aged 6 to 11 years in a randomized Phase 3
trial, supporting potential as a best-in-class option
Only biologic medicine approved for children with oral
corticosteroid-dependent asthma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
approved Dupixent® (dupilumab) 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.
"Despite available treatments, moderate-to-severe asthma can
severely impact children's developing airways, causing sleepless
nights, persistent coughing and wheezing, and potentially
life-threatening exacerbations that require the use of systemic
steroids that can negatively affect growth," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer at Regeneron. "This approval means
that Dupixent, a first-of-its-kind treatment with a
well-established efficacy and safety profile, can now be used by
younger children with certain types of moderate-to-severe asthma in
the U.S. In our pivotal trial, Dupixent helped children aged 6 to
11 years breathe better, suffer fewer asthma attacks and improve
health-related quality of life. We also continue to study Dupixent
in patients with other dermatologic, respiratory and
gastrointestinal conditions where type 2 inflammation may play a
role."
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.,
with 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
the use of multiple courses of systemic corticosteroids that carry
significant risks.
"This FDA approval brings new hope for children who may be
suffering from life-threatening asthma attacks and poor lung
function, affecting their ability to breathe, potentially into
adulthood," said Naimish Patel,
M.D., Head of Global Development in Immunology and Inflammation at
Sanofi. "Dupixent has helped to make a difference to the lives of
many patients and families across three diseases with underlying
type 2 inflammation, with more than 300,000 patients treated
globally. We now have the opportunity to offer a safe and effective
treatment option to children as young as 6 years of age living with
certain types of moderate-to-severe asthma."
The FDA approval is based on data from a Phase 3 randomized,
double-blind, placebo-controlled trial that evaluated the efficacy
and safety of Dupixent combined with standard-of-care asthma
therapy in children with uncontrolled moderate-to-severe asthma.
More than 90% of children in the trial had at least one concurrent
type 2 inflammatory condition.
Among patients who entered the trial with high levels of a
certain type of white blood cell (eosinophils [EOS] ≥300 cells/μl;
n=259), those who added Dupixent (100 mg or 200 mg every two weeks,
based on weight) to standard-of-care experienced:
- Substantially reduced rate of severe asthma attacks, with
a 65% average reduction over one year compared to placebo (0.24
events per year for Dupixent vs. 0.67 for placebo).
- Improved lung function observed as early as two weeks and
sustained for up to 52 weeks, measured by percent predicted
pre-bronchodilator FEV1 (FEV1pp).
-
- At 12 weeks, patients taking Dupixent improved their lung
function by 5.32 percentage points compared to placebo.
- Improved asthma control at 24 weeks, with 81% of patients
reporting a clinically meaningful improvement based on disease
symptoms and impact compared to 64% of placebo patients as measured
by a ≥0.5 improvement on a 7-point scale.
Children with elevated fractional exhaled nitric oxide (FeNO ≥20
ppb), an airway biomarker of inflammation that plays a major role
in asthma, were also evaluated. In this subgroup, children who
added Dupixent to standard-of-care experienced a reduction in the
rate of severe asthma attacks.
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 which 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 is currently under regulatory review for children aged
6 to 11 years with moderate-to-severe asthma in the European
Union and other health authorities worldwide.
About the LIBERTY ASTHMA VOYAGE Trial
The Phase 3
randomized, double-blind, placebo-controlled trial evaluated the
efficacy and safety of Dupixent combined with standard-of-care
asthma therapy in 408 children aged 6 to 11 years with uncontrolled
moderate-to-severe asthma. In this trial, 86% of children had
markers of type 2 inflammation underlying their 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 FEV1pp at week 12. The
FEV1pp seeks to evaluate a patient's change in lung
function compared to their predicted lung function based on age,
height, sex and ethnicity to account for children's growing lung
capacity at different stages of development. Additional secondary
endpoints included mean change from baseline in responder rates as
measured by a ≥0.5 improvement on the Asthma Control Questionnaire
(ACQ) 7-Interviewer Administered.
About Dupixent
Dupixent is an injection under the
skin (subcutaneous injection) at different injection sites. For
pediatric patients aged 6 to 11 years, Dupixent dosing is based on
weight (100 mg every two weeks or 300 mg every four weeks for
children ≥15 to <30 kg and 200 mg every two weeks for children
≥30 kg) and is supplied as a pre-filled syringe. It is also
available as a pre-filled pen for adolescents (12 to 17 years) and
adults at 200 mg and 300 mg doses. 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 if given at
home.
In the U.S., Dupixent is approved as an add-on maintenance
treatment of patients aged 6 years and older with
moderate-to-severe asthma characterized by an eosinophilic
phenotype or with oral corticosteroid-dependent asthma; in patients
aged 6 years and older with uncontrolled moderate-to-severe atopic
dermatitis; and for use with other medicines for the maintenance
treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP)
in adults whose disease is not controlled.
Regeneron and Sanofi are committed to helping patients in the
U.S. who are prescribed Dupixent gain access to the medicine and
receive the support they may need with the DUPIXENT
MyWay® program. For more information, please call
1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.
Dupixent is also approved in Europe, Japan
and other countries around the world for use in certain patients
with asthma or CRSwNP in different age populations, as well as
specific patients with moderate-to-severe atopic dermatitis.
Dupixent is 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, 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 CRSwNP.
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 Inmazeb™
(atoltivimab, maftivimab, and odesivimab-ebgn).
Dupilumab Development Program
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.
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. 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 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
caused the COVID-19 pandemic) on Regeneron's business and its
employees, collaborators, and 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 or otherwise commercialized by Regeneron and/or its
collaborators (collectively, "Regeneron's Products"), and the
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(collectively, "Regeneron's Product Candidates") and research and
clinical programs now underway or planned, including without
limitation Dupixent® (dupilumab); uncertainty of the utilization,
market acceptance, and commercial success of Regeneron's Products
(such as Dupixent) and Regeneron's Product Candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary), including the study discussed in
this press release, on any of the foregoing; 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 Dupixent for the 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, as well as the possible regulatory approval of
Dupixent for children aged 6 to 11 years with moderate-to-severe
asthma in the European Union; the ability of Regeneron's
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issues resulting from the administration of Regeneron's Products
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including serious complications or side effects in connection with
the use of Regeneron's Products and Regeneron's Product Candidates
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ability to continue to develop or commercialize Regeneron's
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such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to, or
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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-COVTM (casirivimab and imdevimab)), other litigation and
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year ended December 31, 2020 and its
Form 10-Q for the quarterly period ended June 30, 2021. Any forward-looking statements are
made based on management's current beliefs and judgment, and the
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including without limitation any financial projection or guidance,
whether as a result of new information, future events, or
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Regeneron uses its media and investor relations website and
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Sanofi Forward-Looking Statements
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Regeneron
Contacts:
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Media
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Sharon
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Tel: +1
914-847-1546
sharon.chen@regeneron.com
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Investor
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Vesna
Tosic
Tel: +1
914-847-5443
Vesna.Tosic@regeneron.com
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Sanofi
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Sally
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Sanofi Investor
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Eva
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Arnaud
Delepine
Nathalie
Pham
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Sanofi Investor
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Felix
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Sanofi IR main
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SOURCE Regeneron Pharmaceuticals