Press Release: Dupixent approved in the EU as the first and only
medicine for young children with eosinophilic esophagitis
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 Giodice
President, 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,
PhD
Executive 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 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 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
study
The 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 Dupixent
Dupixent (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 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,
Instagram, Facebook or X.
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
Sanofi Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 |
sandrine.guendoul@sanofi.com
Evan Berland | + 1 215 432 0234
| evan.berland@sanofi.com
Victor Rouault | + 33 6 70 93 71 40 |
victor.rouault@sanofi.com
Timothy Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Sanofi Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 |
thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93
|arnaud.delepine@sanofi.com
Felix Lauscher | + 1 908 612
7239 | felix.lauscher@sanofi.com
Keita Browne | + 1 781 249 1766 |
keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
Tarik Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 |
thibaud.chatelet@sanofi.com
Regeneron Media Relations
Hannah Kwagh | +1 914-847-6314|
hannah.kwagh@regeneron.com
Regeneron Investor Relations
Mark Hudson | + 914-847-3482 |
mark.hudson@regeneron.com
Sanofi forward-looking
statements
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
“expects”, “anticipates”, “believes”, “intends”, “estimates”,
“plans” and similar expressions. Although Sanofi’s management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that pandemics or other global crises may have on us, our
customers, suppliers, vendors, and other business partners, and the
financial condition of any one of them, as well as on our employees
and on the global economy as a whole. The risks and uncertainties
also include the uncertainties discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2023. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
All trademarks mentioned in this press release are
the property of the Sanofi group apart from VelociSuite and
Regeneron Genetics Center.
Regeneron Forward-Looking Statements and
Use of Digital Media
This press release includes forward-looking statements that involve
risks and uncertainties relating to future events and the future
performance of Regeneron Pharmaceuticals,
Inc. (“Regeneron” or the “Company”), and actual events or
results may differ materially from these forward-looking
statements. Words such as “anticipate,” “expect,” “intend,” “plan,”
“believe,” “seek,” “estimate,” variations of such words, and
similar expressions are intended to identify such forward-looking
statements, although not all forward-looking statements contain
these identifying words. These statements concern, and these risks
and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its
collaborators or licensees (collectively, “Regeneron’s Products”)
and product candidates being developed
by Regeneron and/or its collaborators or licensees
(collectively, “Regeneron’s Product Candidates”) and research and
clinical programs now underway or planned, including without
limitation Dupixent® (dupilumab) for the treatment
of children aged 1 to 11 years with eosinophilic esophagitis;
uncertainty of the utilization, market acceptance, and commercial
success of Regeneron’s Products and Regeneron’s Product Candidates
and the impact of studies (whether conducted
by Regeneron or others and whether mandated or
voluntary), including the studies discussed or referenced in this
press release, on any of the foregoing; the likelihood, timing, and
scope of possible regulatory approval and commercial launch of
Regeneron’s Product Candidates and new indications for Regeneron’s
Products, such as Dupixent for the treatment of chronic pruritus of
unknown origin, bullous pemphigoid, and other potential
indications; the ability of Regeneron’s collaborators, licensees,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron’s Products and
Regeneron’s Product Candidates; the ability
of Regeneron to manage supply chains for multiple
products and product candidates; safety issues resulting from the
administration of Regeneron’s Products (such as Dupixent) and
Regeneron’s Product Candidates in patients, including serious
complications or side effects in connection with the use of
Regeneron’s Products and Regeneron’s Product Candidates in clinical
trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron’s
ability to continue to develop or commercialize Regeneron’s
Products and Regeneron’s Product Candidates; ongoing regulatory
obligations and oversight impacting Regeneron’s Products, research
and clinical programs, and business, including those relating to
patient privacy; the availability and extent of reimbursement of
Regeneron’s Products from third-party payers, including private
payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron’s Products and Regeneron’s Product Candidates; the extent
to which the results from the research and development programs
conducted by Regeneron and/or its collaborators or
licensees may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or
guidance and changes to the assumptions underlying those
projections or guidance; the potential for any license,
collaboration, or supply agreement, including Regeneron’s
agreements with Sanofi and Bayer (or their respective affiliated
companies, as applicable) to be cancelled or terminated; the impact
of public health outbreaks, epidemics, or pandemics (such as the
COVID-19 pandemic) on Regeneron's business; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto (including without limitation
the patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection), other litigation
and other proceedings and government investigations relating to the
Company and/or its operations (including the pending civil
proceedings initiated or joined by the U.S. Department of
Justice and the U.S. Attorney's Office for the District
of Massachusetts), the ultimate outcome of any such proceedings and
investigations, and the impact any of the foregoing may have on
Regeneron’s business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron’s filings with the U.S.
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2023 and its Form 10-Q for the
quarterly period ended September 30, 2024. Any forward-looking
statements are made based on management’s current beliefs and
judgment, and the reader is cautioned not to rely on any
forward-looking statements made
by Regeneron. Regeneron does not undertake any
obligation to update (publicly or otherwise) any forward-looking
statement, including without limitation any financial projection or
guidance, whether as a result of new information, future events, or
otherwise.
Regeneron uses its media and investor
relations website and social media outlets to publish important
information about the Company, including information that may be
deemed material to investors. Financial and other information
about Regeneron is routinely posted and is accessible
on Regeneron's media and investor relations website
(https://investor.regeneron.com) and its LinkedIn page
(https://www.linkedin.com/company/regeneron-pharmaceuticals).
Sanofi (EU:SAN)
Historical Stock Chart
From Nov 2024 to Dec 2024
Sanofi (EU:SAN)
Historical Stock Chart
From Dec 2023 to Dec 2024