Children treated with Dupixent and topical corticosteroids
(TCS) achieved clearer skin, experienced significantly improved
overall disease severity and significantly reduced itch compared to
TCS alone at week 16 in a Phase 3 trial
Long-term safety data from a 52-week open-label extension
trial in this age group reinforce the well-established safety
profile of Dupixent observed across all other approved age
groups
Dupixent is the first and only biologic medicine approved to
treat moderate-to-severe atopic dermatitis from infancy through
adulthood
TARRYTOWN, N.Y. and PARIS, June 7, 2022
/PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and
Sanofi today announced that the U.S. Food and Drug Administration
(FDA) has approved Dupixent® (dupilumab) for children
aged 6 months to 5 years with moderate-to-severe atopic dermatitis
whose disease is not adequately controlled with topical
prescription therapies or when those therapies are not advisable.
Regulatory filings for this age group are underway by the European
Medicines Agency and regulatory authorities in additional
countries.
"Moderate-to-severe atopic dermatitis in babies and young
children is more than just a rash – the intense itch can make them
scratch uncontrollably throughout the day and night and cause their
skin to crack and bleed," said Julie
Block, President and Chief Executive Officer at National
Eczema Association. "Caregivers do their best to manage skincare
routines multiple times a day, but for many, topical treatments are
not enough. We're pleased to see how scientific innovation and
research continues to address unmet needs for the atopic dermatitis
community, and we're hopeful for the positive impact Dupixent can
have for these children and their families."
Atopic dermatitis is a chronic type 2 inflammatory skin disease.
Eighty-five to ninety percent of patients first develop symptoms
before 5 years of age, which can often continue through adulthood.
Symptoms include intense, persistent itch and skin lesions that
cover much of the body, resulting in skin dryness, cracking, pain,
redness or darkening, and crusting and oozing. In the U.S., more
than 75,000 children aged 5 years and younger have
uncontrolled moderate-to-severe disease and are most in need of new
treatment options. Moderate-to-severe atopic dermatitis may also
significantly impact the quality of life of a young child and their
caregivers.
"Young children with moderate-to-severe atopic dermatitis are a
significantly underserved population of patients, who spend
vulnerable years of their lives suffering through the relentless
and far-reaching effects of this chronic disease," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron, and a
principal inventor of Dupixent. "Dupixent has changed the atopic
dermatitis treatment paradigm – significantly clearing skin and
reducing itch – by targeting an underlying cause of this disease
without broadly suppressing the immune system. Today's approval
brings the proven efficacy and, importantly, well-established
safety profile of Dupixent to these young children, making it the
first of its kind to be approved for any U.S. patient aged six
months or older living with this debilitating disease."
"Until today, treatment options in the U.S. for infants and
children under the age of 6 suffering from moderate-to-severe
atopic dermatitis have been limited to topical steroids – which may
be associated with significant safety risks when used long-term.
This has left patients and their caregivers in desperate need of
medicines that can better address the chronic, long-term nature of
the disease," Naimish Patel, M.D,
Senior Vice President, Head of Global Development, Immunology and
Inflammation at Sanofi. "These young people, and their families,
often struggle to cope with the significant impact itch can have
not only on the body, but on many other facets of daily life. This
approval means that Dupixent, with its well-established safety and
efficacy profile, is now available to some of the youngest people
living with this disease."
The FDA evaluated Dupixent under Priority Review, which is
reserved for medicines that represent potentially significant
improvements in efficacy or safety in treating serious conditions.
The approval is based on data that include a Phase 3 trial
evaluating Dupixent every four weeks (200 mg or 300 mg, based on
body weight) plus low-potency topical corticosteroids (TCS) or TCS
alone. The trial met the primary and all secondary endpoints. At 16
weeks, patients who received Dupixent with TCS experienced the
following, compared to TCS alone (placebo):
- 28% achieved clear or almost-clear skin compared to 4% with
placebo, the primary endpoint.
- 53% achieved 75% or greater improvement in overall disease
severity from baseline compared to 11% with placebo, the co-primary
endpoint outside of the U.S.
- 48% achieved clinically meaningful reduction in itch compared
to 9% with placebo.
The safety profile of Dupixent observed through 16 weeks in
children aged 6 months to 5 years was similar to the safety profile
in patients 6 years and older with atopic dermatitis. The long-term
safety profile of Dupixent in children aged 6 months to 5 years
through 52 weeks was also similar to the safety profile observed in
the pivotal trial and consistent with what was observed in older
patients with atopic dermatitis. Hand-foot-and-mouth disease and
skin papilloma were, respectively, reported in 5% and 2% of
Dupixent patients aged 6 months to 5 years, and none of these cases
led to treatment discontinuation.
About the Dupixent Trial
The Phase 3
randomized, double-blind, placebo-controlled trial evaluated the
efficacy and safety of Dupixent added to standard-of-care
low-potency TCS compared to low-potency TCS alone (placebo) in 162
children aged 6 months to 5 years with uncontrolled
moderate-to-severe atopic dermatitis.
The primary endpoints assessed the proportion of patients
achieving an Investigator's Global Assessment (IGA) score of 0
(clear) or 1 (almost clear) and 75% improvement in Eczema Area and
Severity Index (EASI-75) at week 16. Additional outcome measures
included itch reduction, which was assessed using a
caregiver-reported 0 to 10 Numerical Rating Scale, with a
clinically meaningful improvement defined as ≥4-point improvement
at week 16.
Children who completed the trials were eligible to enroll in an
open-label extension trial to assess the safety and efficacy of
long-term treatment with Dupixent in this age group.
About Dupixent
Dupixent is administered as an
injection under the skin (subcutaneous injection) at different
injection sites. In patients aged 6 months to 5 years, Dupixent is
administered with a pre-filled syringe every four weeks based on
weight (200 mg for children ≥5 to <15 kg and 300 mg for children
≥15 to <30 kg). 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. Dupixent
does not require initial lab testing or ongoing lab monitoring.
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 approved for use in certain patients with atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP) or eosinophilic esophagitis in different age populations
in a number of countries around the world. Dupixent is currently
approved across these indications in the U.S. and for one or more
of these indications in the European Union and Japan and more than 60 countries. More than
400,000 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. The Dupixent development program has shown
significant clinical benefit and a decrease in type 2 inflammation
in Phase 3 trials, establishing that IL-4 and IL-13 are key and
central drivers of the type 2 inflammation that plays a major role
in multiple related and often co-morbid diseases. These diseases
include approved indications for Dupixent such as asthma, atopic
dermatitis, CRSwNP and eosinophilic esophagitis, as well as
investigational diseases such as prurigo nodularis.
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
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
approximately one in five of all original, FDA-approved fully human
monoclonal antibodies currently available. This includes
REGEN-COV® (casirivimab and imdevimab),
Dupixent® (dupilumab), Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab),
Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb™ (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
more than 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 in Phase 3
trials, including prurigo nodularis, pediatric eosinophilic
esophagitis, hand and foot atopic dermatitis, chronic inducible
urticaria-cold, chronic spontaneous urticaria, chronic pruritis of
unknown origin, chronic obstructive pulmonary disease with evidence
of type 2 inflammation, chronic rhinosinusitis without nasal
polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis and bullous pemphigoid. 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 adults and children 6 months of age 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
months of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
adults and children 6 years of age 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.
- to treat adults and children 12 years of age and older, who
weigh at least 88 pounds (40 kg), with eosinophilic esophagitis
(EoE). It is not known if DUPIXENT is safe and effective in
children with eosinophilic esophagitis under 12 years of age and
who weigh at least 88 pounds (40 kg).
IMPORTANT SAFETY INFORMATION
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" right before and during treatment 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. DUPIXENT can cause allergic reactions
that can sometimes be severe. Stop using DUPIXENT and tell your
healthcare provider or get emergency help right away if you get any
of the following signs or symptoms: breathing problems or wheezing,
swelling of the face, lips, mouth, tongue or throat, fainting,
dizziness, feeling lightheaded, fast pulse, fever, hives, joint
pain, general ill feeling, itching, skin rash, swollen lymph nodes,
nausea or vomiting, or cramps in your stomach-area.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision, such as blurred vision. Your healthcare provider may send
you to an ophthalmologist for an exam if needed.
- 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, chest pain, worsening shortness of breath, a
feeling of pins and needles or numbness of your arms or legs, or
persistent fever.
- Joint aches and pain. Some people who use DUPIXENT have
had trouble walking or moving due to their joint symptoms, and in
some cases needed to be hospitalized. Tell your healthcare provider
about any new or worsening joint symptoms. Your healthcare provider
may stop DUPIXENT if you develop joint symptoms.
The most common side effects include:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, cold sores in your mouth or on your
lips, and high count of a certain white blood cell
(eosinophilia).
- 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, sometimes
with blurred vision, high count of a certain white blood cell
(eosinophilia), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
- Eosinophilic esophagitis: injection site reactions,
upper respiratory tract infections, cold sores in your mouth or
lips, 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 by your healthcare provider.
It's an injection given under the skin (subcutaneous injection).
Your healthcare provider will decide if you or your caregiver can
inject DUPIXENT. Do not try to prepare and inject
DUPIXENT until you or your caregiver have been trained by your
healthcare provider. In children 12 years of age and older, it's
recommended DUPIXENT be administered by or under supervision of an
adult. In children under 12 years of age, DUPIXENT should be given
by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
About Regeneron
Regeneron is a leading biotechnology company that invents, develops
and commercializes life-transforming medicines for people with
serious diseases. Founded and led for nearly 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and 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 more information, please visit www.Regeneron.com or follow
@Regeneron on Twitter.
About Sanofi
We are an innovative global healthcare
company, driven by one purpose: we chase the miracles of science to
improve people's lives. Our team, across some 100 countries, is
dedicated to transforming the practice of medicine by working to
turn the impossible into the possible. We provide potentially
life-changing treatment options and life-saving vaccine protection
to millions of people globally, while putting sustainability and
social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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
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Regeneron and/or its collaborators or licensees (collectively,
"Regeneron's Products"), and the global economy; the nature,
timing, and possible success and therapeutic applications of
Regeneron's Products and product candidates being developed by
Regeneron and/or its collaborators or licensees (collectively,
"Regeneron's Product Candidates") and research and clinical
programs now underway or planned, including without limitation
Dupixent® (dupilumab) for the treatment of
moderate-to-severe atopic dermatitis in children aged 6 months to 5
years; 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 studies discussed or referenced in this
press release, on any of the foregoing or any potential regulatory
approval of Regeneron's Products (such as Dupixent) and Regeneron's
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 Dupixent for the treatment of hand and foot atopic
dermatitis, prurigo nodularis, eosinophilic esophagitis, chronic
inducible urticaria-cold, chronic spontaneous urticaria, bullous
pemphigoid, chronic obstructive pulmonary disease with evidence of
type 2 inflammation, chronic rhinosinusitis without nasal
polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis, peanut allergy, and other potential
indications; the ability of Regeneron's collaborators, licensees,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
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issues resulting from the administration of Regeneron's Products
(such as Dupixent) and Regeneron's Product Candidates in patients,
including serious 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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competing drugs and product candidates that may be superior to, or
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Ltd. (or their respective affiliated companies, as applicable) to
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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)),
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forward-looking statements are made based on management's current
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Regeneron uses its media and investor relations website and
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Regeneron
Contacts:
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Relations
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Kwagh
Tel: +1
914-847-6314
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Relations
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914-847-5443
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Sanofi
Contacts:
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eva.schaefer-jansen@sanofi.com
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arnaud.delepine@sanofi.com
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