Dupixent® (dupilumab) sBLA for treatment of
eosinophilic esophagitis in children aged 1 to 11 accepted for FDA
Priority Review
- If approved, Dupixent would be the
first and only treatment indicated in the U.S. for children aged 1-
11 with eosinophilic esophagitis, a disease driven by type 2
inflammation that impacts the ability to eat
- Of the approximately 21,000
children under the age of 12 in the U.S. currently being treated
for EoE, about 9,000 do not satisfactorily respond to the
unapproved therapies they have been treated with and potentially
require advanced alternative therapy options
Paris and Tarrytown, N.Y.
September 26, 2023. The
U.S. Food and Drug Administration (FDA) has accepted for Priority
Review the supplemental Biologics License Application (sBLA) for
Dupixent® (dupilumab) to treat children aged 1 to 11 years with
eosinophilic esophagitis (EoE). The target action date for the FDA
decision is January 31, 2024. Dupixent is the first and only
treatment in the U.S. approved for children and adults aged 12
years and older with EoE, weighing at least 40kg.
The sBLA is supported by data from the Phase 3
EoE KIDS trial (Parts A and B) evaluating the efficacy and safety
of Dupixent in children aged 1 to 11 with EoE. In Part A, the
primary endpoint was met for the proportion of patients achieving
histological disease remission (defined as peak esophageal
intraepithelial eosinophil count of ≤6 eosinophils [eos]/high power
field [hpf]) at 16 weeks for tiered dosing regimens based on body
weight, compared to placebo. Part B was an active treatment
extension period evaluating Dupixent for an additional 36 weeks and
showed Dupixent maintained histologic remission for 52 weeks, a
secondary endpoint. Dupixent also led to increases in body weight
for age percentile, which was evaluated as an exploratory endpoint
in Part A and a secondary endpoint in Part B.
Safety results in Parts A and B of the trial
were generally consistent with the known safety profile of Dupixent
in its FDA-approved EoE indication for children and adults aged 12
years and older who weigh at least 40 kg. Adverse events more
commonly observed (≥5%) with Dupixent were COVID-19, rash,
headache, viral gastroenteritis, diarrhea and nausea.
Priority review is granted to therapies that
have the potential to provide significant improvements in the
treatment, diagnosis or prevention of serious conditions.
The potential use of Dupixent in children with
EoE aged 1 to 11 years is currently under clinical development, and
its safety and efficacy have not been fully evaluated by any
regulatory authority in this setting.
About Eosinophilic
EsophagitisEoE is a chronic, progressive disease driven by
type 2 inflammation that damages the esophagus and prevents it from
working properly. In children, common symptoms of EoE include heart
burn, vomiting, abdominal discomfort, trouble swallowing, food
refusal and failure to thrive. These symptoms can impact growth and
development and can cause food-related fear and anxiety, which can
persist through adulthood. Dietary adjustments, including the
elimination of many foods, are the standard treatment for EoE, as
well as the use of treatments not approved for the disease. These
include proton pump inhibitors, swallowed topical corticosteroids,
or in severe cases, a feeding tube, which may be used to ensure
proper caloric intake and weight gain. Continuous treatment of EoE
may be needed to reduce the risk of complications and disease
recurrence.
About DupixentDupixent is a
fully human monoclonal antibody that inhibits the signaling of the
IL-4 and 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 atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo
nodularis and EoE.
Dupixent has received regulatory approvals in
one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in Europe, the U.S. and Japan. More than
600,000 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 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 pediatric EoE, 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 RegeneronRegeneron is a leading
biotechnology company that invents, develops, and commercializes
life- transforming medicines for people with serious diseases.
Founded and led for 35 years by physician-scientists, Regeneron's
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 Regeneron's laboratories. Regeneron's medicines and
pipeline are designed to help patients with eye diseases, allergic
and inflammatory diseases, cancer, cardiovascular and metabolic
diseases, hematologic conditions, infectious diseases, and rare
diseases.Regeneron is accelerating and improving the traditional
drug development process through its 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 additional
information about Regeneron, please visit www.regeneron.com or
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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 some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
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ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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