Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the European Commission (EC) has approved Dupixent®
(dupilumab) to treat eosinophilic esophagitis (EoE) in children as
young as 1 year of age. Specifically, the approval covers children
aged 1 to 11 years who weigh at least 15 kg and who are
inadequately controlled by, intolerant to, or who are not
candidates for conventional medicinal therapy. This expands the
initial approval in the European Union (EU) for EoE in adults and
adolescents and makes Dupixent the first and only medicine
indicated to treat these young patients. Dupixent is also approved
in this young age group in the U.S. and Canada.
“Young children with eosinophilic esophagitis are at the
beginning of their life-long journey with a disease that challenges
their ability to eat,” said Roberta Giodice, President, ESEO
Italia. “Parents of these children have often relied on restrictive
diets that do not specifically address the disease and can stunt
their growth at a critical time in development that could impact
them for years to come. We are pleased that research continues and
offers new treatment options to improve the quality of their
care.”
“Eosinophilic esophagitis presents a unique challenge in young
children, who struggle with their basic ability to eat during a
time in their lives where proper nutrition is essential for growth
and development,” said George D. Yancopoulos, M.D., Ph.D., Board
co-Chair, President and Chief Scientific Officer at Regeneron, and
a principal inventor of Dupixent. “This approval will bring the
proven efficacy and demonstrated safety profile of Dupixent to this
vulnerable, young population that has already been established in
older EoE patients and has the potential to transform the standard
of care for children with EoE who previously had no therapies
specifically approved for them.”
The approval is based on the two-part (Part A and B) EoE KIDS
Phase 3 trial in children aged 1 to 11 years, which established a
bridge showing the response to Dupixent in children with EoE is
similar to that of the approved adult and adolescent populations.
In Part A, children who received a higher dose of Dupixent (n=37)
based on a weight-based dosing regimen experienced the following
outcomes, compared to placebo (n=34) at 16 weeks:
- 68% achieved histological disease remission (≤6
eosinophils/high power field) compared to 3%, the primary endpoint.
These results were sustained for up to one year in Part B of the
trial.
- 86% reduction in peak esophageal intraepithelial eosinophil
count from baseline compared to a 21% increase.
- Reductions in abnormal endoscopic findings and disease severity
and extent (as measured at the microscopic level).
- Nominally significant improvement in the frequency and severity
of EoE signs, and numerical reduction in days with at least one
sign of EoE, based on caregiver-reported outcomes.
The safety results in the EoE KIDS trial were generally
consistent with the known safety profile of Dupixent in adolescents
and adults with EoE. The most common adverse reactions for Dupixent
overall are injection site reactions, conjunctivitis,
conjunctivitis allergic, arthralgia, oral herpes and eosinophilia.
In addition, the adverse reaction of injection site bruising was
reported in EoE. In patients aged 1 to 11 years, adverse events
more commonly observed with Dupixent (≥10%) in either weight-based
dosing regimen compared to placebo during Part A were COVID-19,
nausea, injection site pain and headache. The long-term safety
profile of Dupixent evaluated in Part B was similar to that
observed during Part A.
“Up to half of all children in the EU with eosinophilic
esophagitis remain uncontrolled despite existing standard of care
treatment options, and, as a result, many of these young patients
struggle to maintain weight due to serious symptoms such as
difficulty swallowing and vomiting,” said Houman Ashrafian, M.D.,
Ph.D., Executive Vice President, Head of Research and Development
at Sanofi. “This milestone provides an important new treatment for
pediatric patients who were previously without options specifically
approved for their disease. With this novel approach to addressing
an underlying cause of eosinophilic esophagitis, Dupixent has the
potential to give these young children a better chance to
thrive.”
About Eosinophilic EsophagitisEoE is a chronic,
progressive disease associated with type 2 inflammation that is
thought to be responsible for damaging the esophagus and impairing
its function. Diagnosis is difficult, as symptoms can be mistaken
for other conditions leading to delays in diagnosis. EoE can
severely impact a child’s ability to eat and may also cause
vomiting, abdominal pain, difficulty swallowing, decreased appetite
and challenges thriving. Continuous management of EoE may be needed
to reduce the risk of complications and disease progression.
About the Dupixent Pediatric Eosinophilic Esophagitis
Trial The EoE KIDS Phase 3 trial was a randomized,
double-blind, placebo-controlled trial evaluating the efficacy and
safety of Dupixent in children aged 1 to 11 years with EoE. Part A
enrolled 71 patients and evaluated Dupixent at a weight-based dose
regimen, compared to placebo, for 16 weeks. Part B was a 36-week
extended active treatment period in which eligible children from
Part A in the Dupixent group continued treatment, while those in
the placebo group switched to Dupixent. Patients included in this
trial were previously treated and did not respond to conventional
medicinal therapies, including proton pump inhibitors and/or
swallowed topical corticosteroids.
The primary endpoint was histologic remission at 16 weeks, and
secondary endpoints included assessments of endoscopic and
histopathologic measures of the severity of disease along with
caregiver-reported clinical signs and symptoms of EoE. The 108-week
open-label extension period (Part C) to evaluate longer-term
outcomes was recently completed.
Results from the trial were published in The New England
Journal of Medicine.
About DupixentDupixent is an injection
administered under the skin (subcutaneous injection) at different
injection sites. In patients aged 1 to 11 years with EoE, Dupixent
is administered every other week (200 mg for children ≥15 to <30
kg, 300 mg for children ≥30 to <40 kg) or every week (300 mg for
children ≥40 kg), based on weight. Dupixent is intended for use
under the guidance of a healthcare professional and can be given in
a clinic or at home administered by a caregiver after training by a
healthcare professional.
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 two of the
key and central drivers of the type 2 inflammation that plays a
major role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60
countries in one or more indications including certain patients
with atopic dermatitis, asthma, chronic rhinosinusitis with nasal
polyps (CRSwNP), eosinophilic esophagitis (EoE), prurigo nodularis,
chronic spontaneous urticaria (CSU), and chronic obstructive
pulmonary disease (COPD) in different age populations. More than
1,000,000 patients are being treated with Dupixent globally.1
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 a
substantial proportion of all original, FDA-approved or authorized
fully human monoclonal antibodies. This includes REGEN-COV®
(casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and
odesivimab-ebgn) and Veopoz™ (pozelimab-bbfg).
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 chronic pruritus of unknown origin 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 eczema (atopic dermatitis or AD) 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. 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 polyps (CRSwNP) in adults and children 12
years of age and older whose disease is not controlled. It is not
known if DUPIXENT is safe and effective in children with chronic
rhinosinusitis with nasal polyps under 12 years of age.
- to treat adults and children 1 year of age and older with
eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15
kg). It is not known if DUPIXENT is safe and effective in children
with eosinophilic esophagitis under 1 year of age, or who weigh
less than 33 pounds (15 kg).
- to treat adults with prurigo nodularis (PN). It is not known if
DUPIXENT is safe and effective in children with prurigo nodularis
under 18 years of age.
- with other medicines for the maintenance treatment of adults
with inadequately controlled chronic obstructive pulmonary disease
(COPD) and a high number of blood eosinophils (a type of white
blood cell that may contribute to your COPD). DUPIXENT is used to
reduce the number of flare-ups (the worsening of your COPD symptoms
for several days) and can improve your breathing. It is not known
if DUPIXENT is safe and effective in children with chronic
obstructive pulmonary disease under 18 years of age.
DUPIXENT is not used to relieve sudden breathing problems and
will not replace an inhaled rescue medicine.
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,
chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis,
prurigo nodularis, or chronic obstructive pulmonary disease and
also have asthma. Do not change or stop your other
medicines, including corticosteroid medicine or other asthma
medicine, without talking to your healthcare provider. This may
cause other symptoms that were controlled by those medicines 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:
- Eczema: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, dry eye, cold sores in your mouth or
on your lips, and high count of a certain white blood cell
(eosinophilia).
-
Asthma:
injection site reactions, high count of a certain white blood cell
(eosinophilia), pain in the throat (oropharyngeal pain), and
parasitic (helminth) infections.
-
Chronic
Rhinosinusitis
with
Nasal
Polyps:
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), gastritis,
joint pain (arthralgia), trouble sleeping (insomnia), and
toothache.
- Eosinophilic Esophagitis: injection site
reactions, upper respiratory tract infections, cold sores in your
mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid
inflammation, including redness, swelling, and itching, sometimes
with blurred vision, herpes virus infections, common cold symptoms
(nasopharyngitis), dizziness, muscle pain, and diarrhea.
- Chronic Obstructive Pulmonary Disease:
injection site reactions, common cold symptoms (nasopharyngitis),
high count of a certain white blood cell (eosinophilia), viral
infection, back pain, inflammation inside the nose (rhinitis),
diarrhea, gastritis, joint pain (arthralgia), toothache, headache,
and urinary tract infection.
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 6 months to less than 12 years of age,
DUPIXENT should be given by a caregiver.
Please
see
accompanying
full
Prescribing
Information
including
Patient
Information.
About RegeneronRegeneron (NASDAQ: REGN) is a
leading biotechnology company that invents, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to numerous approved treatments and product
candidates in development, most 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, neurological
diseases, hematologic conditions, infectious diseases, and rare
diseases.
Regeneron pushes the boundaries of scientific discovery
and accelerates drug development using our
proprietary technologies, such as VelociSuite®, which produces
optimized fully human antibodies and new classes of bispecific
antibodies. We are shaping the next frontier of medicine with
data-powered insights from the Regeneron Genetics
Center® and pioneering genetic medicine platforms, enabling us
to identify innovative targets and complementary approaches to
potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow
Regeneron on LinkedIn, Instagram, Facebook or X.
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 the world, 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
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“intend,” “plan,” “believe,” “seek,” “estimate,” variations of such
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the nature, timing, and possible success and therapeutic
applications of products marketed or otherwise commercialized
by Regeneron and/or its collaborators or licensees
(collectively, “Regeneron’s Products”) and product candidates being
developed by Regeneron and/or its collaborators or
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research and clinical programs now underway or planned, including
without limitation Dupixent® (dupilumab) for the treatment of
children aged 1 to 11 years with eosinophilic esophagitis;
uncertainty of the utilization, market acceptance, and commercial
success of Regeneron’s Products and Regeneron’s Product Candidates
and the impact of studies (whether conducted
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and/or its operations (including the pending civil proceedings
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forward-looking statements as defined in the Private Securities
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Regeneron
Contacts: Media
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Victor.Rouault@sanofi.com Timothy
Gilbert Tel: +1
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Investor
Relations Mark HudsonTel: +1
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Relations Thomas Kudsk LarsenTel:
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