Press Release: Dupixent recommended for EU approval by the CHMP to
treat eosinophilic esophagitis in children as young as 1 year old
Dupixent recommended for EU approval by the
CHMP to treat eosinophilic esophagitis in children as young as 1
year old
- Recommendation based on a phase 3
study showing a significantly greater proportion of children on
Dupixent achieved histological remission, compared to placebo,
consistent with improvements seen in adults and adolescents
- If approved, Dupixent would be the
first and only medicine in the EU indicated for EoE in this age
group
Paris and Tarrytown, NY, September 20,
2024. The European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) adopted a positive opinion
recommending the expanded approval of Dupixent (dupilumab) in the
European Union (EU) for eosinophilic esophagitis (EoE) in children
down to 1 year of age. The recommendation is for 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. The European Commission is expected
to announce a final decision in the coming months. Dupixent is
already approved in the EU for certain adults and adolescents aged
12 years and older with EoE.
The positive CHMP opinion is supported by a
two-part (Part A and B) EoE KIDS phase 3 study in children aged one
to 11 years. In Part A, a significantly greater proportion of
children receiving weight-based doses of Dupixent achieved
histological disease remission at week 16, compared to placebo,
with results sustained for up to one year in Part B. At week 16,
caregivers of children treated with Dupixent also observed
improvements in the frequency and severity of EoE signs, and fewer
days with at least one sign of EoE, compared to placebo. These data
established a bridge showing the response to Dupixent in children
with EoE is similar to that of the approved adult and adolescent
EoE populations.
The safety results in the EoE KIDS study were
generally consistent with the known safety profile of Dupixent in
adolescents and adults with EoE. AEs 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.
Results from the study were recently published
in The New England Journal of Medicine.
The use of Dupixent in children aged one to 11
years with EoE is investigational in the EU and is not yet
approved.
About EoE
EoE 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 and there are 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 Dupixent
Dupixent (dupilumab) 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 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 program
Dupilumab 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 Regeneron
Regeneron (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,
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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
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