Dupixent late-breaking positive phase 3 data in
chronic spontaneous urticaria to be presented at ACAAI
- Dupixent significantly reduced itch
and hive activity from baseline; 41% of patients achieved
well-controlled disease status
- Confirmatory data to support US
regulatory resubmission by year-end; if approved, Dupixent would be
the first new targeted treatment for people living with chronic
spontaneous urticaria in more than 10 years
- More than 300,000 people in the US
suffer from chronic spontaneous urticaria that is inadequately
controlled by antihistamines
Paris and Tarrytown, NY, October 24,
2024. Positive data from the phase 3 LIBERTY-CUPID Study C
evaluating the investigational use of Dupixent (dupilumab) in
biologic-naive patients with uncontrolled chronic spontaneous
urticaria (CSU) who receive background therapy with antihistamines
will be presented in a late-breaking oral presentation at the
American College of Allergy, Asthma and Immunology (ACAAI) 2024
Annual Scientific Meeting in Boston, Massachusetts. Results showed
treatment with Dupixent significantly reduced itch and urticaria
activity (itch and hive) scores from baseline, and a higher
proportion of patients achieved well-controlled disease status,
compared to placebo.
Thomas B. Casale,
M.D.Professor, Internal Medicine, Morsani College of
Medicine at the University of South Florida, USA “Chronic
spontaneous urticaria is an inflammatory skin condition that
affects patients with unpredictable episodes of intense itching and
hives, often severely impacting their daily lives. These data
confirm results seen in the previous Study A and reinforce the
potential of Dupixent to significantly alleviate symptoms for
patients, helping them to better control this challenging
disease.”
Study C enrolled 151 children and adults who were
randomized to receive Dupixent (n=74) or placebo (n=77) added to
standard-of-care histamine-1 (H1) antihistamines. At 24 weeks,
Dupixent demonstrated significant improvements compared to placebo
on:
- Itch severity score (8.64- vs.
6.10-point reduction from baseline; p=0.02)
- Urticaria (itch and hive) activity
score (15.86- vs. 11.21-point reduction from baseline; p=0.02)
- Well-controlled disease status
(urticaria activity score ≤6; 41% vs. 23%; p=0.005)
- Complete response (urticaria activity
score=0; 30% vs. 18%; p=0.02)
The safety results in Study C were generally
consistent with the known safety profile of Dupixent in its
approved dermatological indications. Overall rates of treatment
emergent adverse events (AEs) were 53% for both Dupixent and
placebo. AEs more commonly observed with Dupixent (≥5%) compared to
placebo included injection site reactions (12% vs. 4%), accidental
overdose (7% vs. 3%) and COVID-19 infection (8% vs. 5%).
Dupixent has been approved for CSU in Japan, the
United Arab Emirates (UAE) and is also under regulatory review in
the European Union based on earlier trial readouts. Outside of
Japan and the UAE, the safety and efficacy of Dupixent for CSU has
not been fully evaluated by any regulatory authority.
About CSUCSU is a chronic
inflammatory skin disease driven in part by type-2 inflammation,
which causes sudden and debilitating hives and persistent itch. CSU
is typically treated with H1 antihistamines, medicines that target
H1 receptors on cells to control symptoms of urticaria. However,
the disease remains uncontrolled despite antihistamine treatment in
many patients, some of whom are left with limited alternative
treatment options. These individuals continue to experience
symptoms that can be debilitating and significantly impact their
quality of life. More than 300,000 people in the US suffer from CSU
that is inadequately controlled by antihistamines.
About the Dupixent phase 3 CSU program
(LIBERTY-CUPID)The LIBERTY-CUPID Phase 3 study program
evaluating Dupixent for CSU consists of Study A, Study B, and Study
C.
Study C was a randomized, double-blind,
placebo-controlled clinical study that evaluated the efficacy and
safety of Dupixent as an add-on to standard-of-care antihistamines
compared to antihistamines alone in 151 patients aged six years and
older with CSU who remained symptomatic despite antihistamine use
and were not previously treated with omalizumab (i.e.,
biologic-naïve). The primary endpoint assessed the change from
baseline in itch at 24 weeks (measured by the weekly itch severity
score [ISS7], 0-21 scale). Secondary endpoints at 24 weeks,
measured by the weekly urticaria activity score (UAS7) included the
change from baseline in itch and hives (UAS7, 0-42 scale),
proportion of patients achieving well-controlled disease status
(UAS7 ≤6), and complete response (UAS7=0).
About DupixentDupixent (dupilumab)
is a fully human monoclonal antibody that inhibits the signaling of
the IL4 and 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 type-2 inflammation that play 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, eosinophilic esophagitis, 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 in part 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 RegeneronRegeneron (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
Guendoul | + 33 6 25 09 14 25 |
sandrine.guendoul@sanofi.comEvan
Berland | + 1 215 432 0234
| evan.berland@sanofi.comVictor Rouault | +
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Regeneron Media RelationsIlana
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Regeneron Investor RelationsMark
Hudson | + 914-847-3482 | mark.hudson@regeneron.com
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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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generally beyond the control of Sanofi, that could cause actual
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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
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
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and any related future litigation and the ultimate outcome of such
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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
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are the property of the Sanofi group with the exception of
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
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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 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 spontaneous
urticaria (“CSU”) as discussed in this press release as well as 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 or any
potential regulatory approval of Regeneron’s Products (such as
Dupixent for the treatment of CSU in countries other than Japan and
the United Arab Emirates) and Regeneron’s Product Candidates; 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
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and clinical programs, and business, including those relating to
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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
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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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material to investors. Financial and other information about
Regeneron is routinely posted and is accessible on Regeneron's
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