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 EoEEoE 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 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 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
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 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 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 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 RelationsSandrine
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statementsThis 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
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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
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and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
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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
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All trademarks mentioned in this press release
are the property of the Sanofi group with the exception of
VelociSuite and Regeneron Genetics Center.
Regeneron Forward-Looking
StatementsThis 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); the impact of the opinion
adopted by the European Medicines Agency's Committee for Medicinal
Products for Human Use discussed in this press release on the
potential approval by the European Commission of Dupixent to treat
eosinophilic esophagitis (“EoE”) in children aged 1 to 11 years;
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 pediatric EoE in the European Union as discussed in
this press release as well as for the treatment of chronic pruritus
of unknown origin, bullous pemphigoid, and other potential
indications; 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 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
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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 June 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
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about the Company, including information that may be deemed
material to investors. Financial and other information about
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Sanofi (EU:SAN)
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