Dupixent approved in the EU as the first and only
medicine for young children with eosinophilic esophagitis
- Approval based on
phase 3 data showing significantly more children aged one to 11
years on Dupixent achieved histological disease remission at 16
weeks compared to placebo, which was sustained up to one year
- Dupixent is the
first-ever medicine in the EU indicated to treat these young
patients, who persistently struggle to eat at a critical stage in
life where growth is crucial
Paris and Tarrytown, NY, November 6,
2024. The European Medicines Agency has approved Dupixent
(dupilumab) to treat eosinophilic esophagitis (EoE) in children as
young as one year of age. Specifically, the approval covers
children aged one 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 US and Canada.
Roberta GiodicePresident, ESEO
Italia“Young children with eosinophilic esophagitis are at the
beginning of their life-long journey with a disease that challenges
their ability to eat. 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.”
Houman Ashrafian, MD, PhDExecutive
Vice President, Head of Research and Development, Sanofi “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. 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.”
The approval is based on the two-part (Part A and
B) EoE KIDS phase 3 study in children aged one 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 study.
- 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 study 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 one 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.
George D. Yancopoulos, M.D.,
Ph.D.Board co-Chair, President, and Chief Scientific
Officer at Regeneron “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. 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.”
About EoEEoE 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 EoE
studyThe EoE KIDS phase 3 study was a randomized,
double-blind, placebo-controlled study evaluating the efficacy and
safety of Dupixent in children aged one 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 study were published in The New
England Journal of Medicine.
About DupixentDupixent (dupilumab)
is an injection administered under the skin (subcutaneous
injection) at different injection sites. In patients aged one 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 is a fully human monoclonal antibody that
inhibits the signaling of the interleukin-4 (IL4) and
interleukin-13 (IL13) 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 studies,
establishing that IL4 and IL13 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, EoE, prurigo nodularis, chronic spontaneous
urticaria, and chronic obstructive pulmonary disease in different
age populations. More than 1,000,000 patients are being treated
with Dupixent globally.
Dupilumab development
programDupilumab is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement. To date,
dupilumab has been studied across more than 60 clinical studies
involving more than 10,000 patients with various chronic diseases
driven in part by type-2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron are studying dupilumab in a broad
range of diseases driven by type-2 inflammation or other allergic
processes in phase 3 studies, 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.
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
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For more information, please visit
www.Regeneron.com or follow Regeneron on LinkedIn,
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About SanofiWe 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
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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
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