Press Release: Dupixent® FDA approved as first and only treatment
indicated for children aged 1 year and older with eosinophilic
esophagitis (EoE)
Dupixent® FDA approved as first and only
treatment indicated for children aged 1 year and older with
eosinophilic esophagitis (EoE)
- Approval based on Phase 3 EoE KIDS
trial showing a greater proportion of children taking Dupixent
achieved histological remission compared to
placebo
- Expanded indication marks second
disease for which Dupixent is approved in children this young,
underscoring the commitment to bringing therapies to young patients
with significant unmet needs
- EoE is one of five FDA-approved
indications for Dupixent in the U.S. for which type 2 inflammation
is an underlying driver
Paris and Tarrytown, N.Y. January 25,
2024. The U.S. Food and Drug Administration (FDA) has
approved Dupixent® (dupilumab) for the treatment of pediatric
patients aged 1 to 11 years, weighing at least 15 kg, with
eosinophilic esophagitis (EoE). Dupixent is now the first and only
medicine approved in the U.S. specifically indicated to treat these
patients. This approval expands the initial FDA approval for EoE in
May 2022 for patients aged 12 years and older, weighing at least 40
kg. The FDA evaluated Dupixent for this expanded indication under
Priority Review, which is reserved for medicines that represent
potentially significant improvements in efficacy or safety in
treating serious conditions.
EoE is a chronic, progressive disease driven in
part by type 2 inflammation that damages the esophagus and impairs
its function. EoE can severely impact a child’s ability to eat, and
they may experience heartburn, vomiting, abdominal discomfort,
trouble swallowing, food refusal and failure to thrive. These
symptoms can adversely impact their growth and development.
Continuous treatment of EoE may be needed to reduce the risk of
complications and disease progression. Approximately 21,000
children under the age of 12 in the U.S. are currently being
treated for EoE with unapproved therapies. However, the actual
prevalence of children with the disease is likely higher, given
symptoms can be mistaken for other conditions and there are delays
in diagnosis.
Naimish Patel, M.D.
Head of Global Development, Immunology and
Inflammation at Sanofi“Young children with eosinophilic esophagitis
have significant unmet medical needs; despite existing treatment
options, 40% of these children in the U.S. under the age of 12
continue to experience symptoms of this disease. Today’s approval
underscores our commitment to bringing therapies to young patients
with unmet needs and also brings hope to these patients who are at
a critical age where struggling to eat and maintain weight directly
impacts their overall nutritional intake and development.”
The FDA approval is based on data from the Phase
3 EoE KIDS trial with two parts (Part A and Part B) evaluating the
efficacy and safety of Dupixent in children aged 1 to 11 years with
EoE. At 16 weeks, 66% of children who received higher dose Dupixent
at tiered dosing regimens based on weight (n=32) achieved
histological disease remission (≤6 eosinophils/high power field),
the primary endpoint, compared to 3% for placebo (n=29).
Histological remission was sustained at week 52, with 17 of 32
(53%) children treated with Dupixent in Parts A and B. Histological
remission was also achieved at week 52 in 8 of 15 (53%) children
who switched to Dupixent from placebo in Part B. In addition, a
greater decrease in the proportion of days with one or more signs
of EoE based on Pediatric EoE Sign/Symptom Questionnaire-caregiver
version (PESQ-C) was observed in children treated with Dupixent at
16 weeks compared to placebo.
George D. Yancopoulos, M.D.,
Ph.D.Board co-chair, President and Chief Scientific
Officer at Regeneron
“Young children are some of the most vulnerable
patients with eosinophilic esophagitis, or EoE, as this
debilitating and progressive disease threatens their basic ability
to eat. Until today, these children had no approved treatment
options specifically for EoE, leaving many with unapproved
medicines that failed to target the root cause of their disease.
With this approval, Dupixent becomes the first and only treatment
option for EoE patients aged 1 year and older, weighing at least 15
kg. By targeting the underlying type 2 inflammation that
contributes to this disease, Dupixent has the potential to
transform the standard of care for these children as it has for
adults and adolescents with EoE.”
The safety profile of Dupixent observed through
16 weeks in children aged 1 to 11 years weighing at least 15 kg was
generally similar to the safety profile of Dupixent observed
through 24 weeks in adult and pediatric patients aged 12 years and
older with EoE. The most common adverse events (≥2%) more
frequently observed with Dupixent than placebo were injection site
reactions, upper respiratory tract infections, arthralgia (joint
pain) and herpes viral infections. In EoE KIDS Part B, one case of
helminth infection was reported in the Dupixent arm.
About the Dupixent Pediatric
Eosinophilic Esophagitis Trial The Phase 3
randomized, double-blind, placebo-controlled trial evaluated the
efficacy and safety of Dupixent in children aged 1 to 11 years,
weighing at least 15 kg, with EoE, as determined by histological,
endoscopic and patient- or caregiver-reported measures. At
baseline, 97% of these patients had at least one co-existing type 2
inflammatory disease, such as food allergy, allergic rhinitis,
asthma and atopic dermatitis.
Part A, a 16-week, double-blind,
placebo-controlled treatment period, enrolled 61 patients
and evaluated the safety and efficacy of Dupixent in a tiered,
weight-based dosing schema. The primary endpoint was histological
disease remission, which was defined as peak esophageal
intraepithelial eosinophil count of ≤6 eosinophils (eos)/high power
field (hpf). Changes in caregiver-reported symptoms (proportion of
days with 1 or more EoE signs [e.g., stomach pain, vomiting, food
refusal]) were evaluated using PESQ-C.
Part B was a 36-week extended active treatment
period (n=47) in which eligible children from Part A in the
Dupixent group continued to receive their dose level and those in
the placebo group in Part A switched to Dupixent.
About DupixentDupixent, 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 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, and 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 800,000 patients
are being treated with Dupixent globally.
Dupilumab Development
ProgramDupilumab 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, chronic obstructive pulmonary disease (COPD) 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 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
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.
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 for over 35 years by
physician-scientists, our 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 our laboratories. Our
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 our 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 more information about Regeneron, please
visit www.Regeneron.com or follow Regeneron on LinkedIn.
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