Press Release: Dupixent positive phase 3 data in children one to 11
years of age with eosinophilic esophagitis published in NEJM
Dupixent positive phase 3 data in children one to
11 years of age with eosinophilic esophagitis published in NEJM
- Majority of patients in this age group
with eosinophilic esophagitis receiving Dupixent achieved
histologic remission, with improvements sustained up to one
year
- Dupixent is the first-and-only
medicine indicated for eosinophilic esophagitis in the US for this
age group
Paris and Tarrytown, NY, June 26,
2024. The New England Journal of Medicine has published
results from a positive phase 3 study of Dupixent (dupilumab) in
children aged one to 11 years with eosinophilic esophagitis (EoE).
The study showed a greater proportion of those receiving
weight-tiered higher dose Dupixent experienced significant
improvements in many key disease measures of EoE, compared to
placebo at week 16. Data from the study were the basis for the US
Food and Drug Administration Priority Review and approval of
Dupixent in children aged one to 11 years with EoE weighing at
least 15 kg, as well as for the regulatory submission that is
currently under review by the European Medicines Agency for this
age group.
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 abdominal pain, trouble
swallowing, heartburn, vomiting and failure to thrive. Continuous
management of EoE may be needed to reduce the risk of complications
and disease progression.
Mirna Chehade, M.D., MPHMount
Sinai Center for Eosinophilic Disorders, Icahn School of Medicine
at Mount Sinai, New York, NY, and principal investigator of the
study“The NEJM publication of these phase 3 dupilumab results is a
testament to the importance of these data and potential for
dupilumab to change the standard of care for many young children
living with eosinophilic esophagitis. These children commonly
experience feeding difficulties, food refusal and failure to thrive
during a critical time of their growth and development. These data
showed weight-tiered higher dose dupilumab significantly improved
key eosinophilic esophagitis histologic, endoscopic, and cellular
measures in children as young as 1 year old with sustained results
for up to one year. These results reinforce the positive results
seen in older patients with eosinophilic esophagitis and strengthen
our understanding of IL4 and IL13 as key drivers of the type 2
inflammation underlying this disease.”
As published, a significantly greater proportion
of children receiving either a weight-tiered higher or lower dose
regimen of Dupixent achieved histologic remission at week 16 in
part A of the study, compared with placebo. Additionally, those
treated with higher dose Dupixent experienced significant
improvements in disease severity assessed by endoscopic measures,
with improvements sustained for up to one year. Those receiving
lower dose Dupixent experienced improvements that were either
comparable or numerically lower than the higher dose group.
Dupixent also led to numerical improvement in body weight for age
percentile by week 16 and sustained to one year, which was
evaluated as an exploratory endpoint in part A and a secondary
endpoint in part B.
Safety results were generally consistent with the
known safety profile of Dupixent in adolescents and adults with
EoE. Adverse events more commonly observed with Dupixent (≥10%) in
either weight-based dosing regimen versus placebo in the study were
COVID-19, nausea, injection site pain and headache during part A.
The long-term safety profile of Dupixent in children aged one to 11
years through part B was similar to that observed during part A. In
part B, one case of helminth infection was reported with
Dupixent.
For patients in the US with EoE weighing at least
15 kg, the FDA-approved dosage for Dupixent is 200mg or 300mg every
other week, or 300mg weekly, based on weight.
Dr. Mirna Chehade has served as a paid consultant
for Sanofi and Regeneron and has received research grant funding
from Regeneron.
About the Dupixent pediatric
eosinophilic esophagitis studyThe phase 3 randomized,
double-blind, placebo-controlled study evaluated the efficacy and
safety of Dupixent in children aged one to 11 years with EoE. Part
A enrolled 102 patients and evaluated Dupixent at a weight-tiered
higher dose or lower 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
maintained their weight-tiered higher or lower dose level, while
those in the placebo group switched to weight-tiered higher or
lower dose Dupixent.
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
clinical signs and symptoms of EoE. Change in body weight for age
percentile was evaluated as an exploratory endpoint in part A and
as a secondary endpoint in part B. The study is ongoing with a
108-week open-label extension period (part C) to evaluate
longer-term outcomes.
About DupixentDupixent (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 polyposis, eosinophilic esophagitis, prurigo nodularis
and chronic spontaneous urticaria in different age populations.
More than 850,000 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 spontaneous urticaria,
chronic pruritus of unknown origin, chronic obstructive pulmonary
disease with evidence of type 2 inflammation 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
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About SanofiWe are an innovative global healthcare
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