Dupixent® (dupilumab) application for treatment of
chronic spontaneous urticaria (CSU) in adults and adolescents
accepted for FDA review
- More than 300,000 people in the U.S.
suffer from CSU that is inadequately controlled by
antihistamines
Paris and Tarrytown, N.Y.
March 7,
2023. The U.S. Food and Drug
Administration (FDA) has accepted, for review, the supplemental
Biologics License Application (sBLA) for Dupixent® (dupilumab) to
treat adults and adolescents aged 12 years and older with chronic
spontaneous urticaria (CSU) that is not adequately controlled with
the current standard of care, H1 antihistamine treatment. The
target action date for the FDA decision is October 22, 2023.
CSU is an inflammatory skin condition driven in
part by type 2 inflammation, which causes sudden and debilitating
hives and swelling on the skin. Swelling, called angioedema, may
occur most commonly on the face, hands and feet, but can also
affect the throat and upper airways. CSU is typically treated with
H1 antihistamines, medicines that target histamine-1 receptors on
cells to control symptoms of urticaria. However, the disease
remains uncontrolled in up to 50% of patients, who are left with
limited alternative treatment options. These individuals continue
to experience symptoms, including persistent itch or burning
sensations that can be debilitating and significantly impact
quality of life.
The sBLA is supported by data from two Phase 3
trials (LIBERTY-CUPID Studies A and B), evaluating Dupixent in two
different patient populations with uncontrolled CSU. Study A was
conducted in CSU patients who were uncontrolled on standard-of-care
antihistamines with efficacy and safety data supporting the
submission, while Study B was conducted in CSU patients who were
uncontrolled on standard-of-care antihistamines and refractory to
omalizumab with results providing additional supporting data.
The potential use of Dupixent in CSU is currently
under clinical development, and the safety and efficacy have not
been fully evaluated by any regulatory authority.
About the CSU
Clinical Trial ProgramThe clinical trial program,
known as LIBERTY-CUPID, includes Studies A and B, two Phase 3
randomized, double-blind, placebo-controlled trials evaluating the
efficacy and safety of Dupixent in two different patient
populations with uncontrolled CSU. Study A evaluated Dupixent as an
add-on therapy to standard-of-care H1 antihistamines compared to
antihistamines alone in 138 patients with CSU aged 6 years and
older who remained symptomatic despite antihistamine use and were
not previously treated with omalizumab. Study B evaluated Dupixent
in 108 patients with CSU aged 12 to 80 years who remained
symptomatic despite standard-of-care treatment and were intolerant
or incomplete responders to omalizumab.
In addition to CSU, Sanofi and Regeneron are also
studying Dupixent in chronic inducible urticaria triggered by cold
(LIBERTY-CINDU CUrIADS program) in an ongoing Phase 3 trial.
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 eosinophilic
esophagitis (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 500,000 patients have been
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,
Sanofi and Regeneron 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, atopic hand and foot
dermatitis, chronic inducible urticaria-cold, CSU, chronic pruritus
of unknown origin, chronic obstructive pulmonary disease with
evidence of type 2 inflammation, chronic rhinosinusitis without
nasal polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis 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 for 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to nine FDA-approved treatments and numerous
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, pain, 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, please visit
www.Regeneron.com or follow @Regeneron on Twitter.
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
Sanofi Media RelationsSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.com
Sanofi Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39 |
eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 06 73 69 36 93 |
arnaud.delepine@sanofi.comCorentine Driancourt | +
33 06 40 56 92 | corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comTarik Elgoutni | + 1 617
710 3587 | tarik.elgoutni@sanofi.comNathalie Pham
| + 33 07 85 93 30 17 | nathalie.pham@sanofi.com
Regeneron Media RelationsTammy
Allen | + 1 914 306 2698 |
tammy.allen@regeneron.com
Regeneron Investor RelationsVesna
Tosic | + 914 847 5443 |
vesna.tosic@regeneron.com
Sanofi Forward-Looking
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
“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 COVID-19 will 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, 2022. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
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 impact of SARS-CoV-2
(the virus that has caused the COVID-19 pandemic) on Regeneron’s
business and its employees, collaborators, and suppliers and other
third parties on which Regeneron relies, Regeneron’s and its
collaborators’ ability to continue to conduct research and clinical
programs, Regeneron’s ability to manage its supply chain, net
product sales of products marketed or otherwise commercialized by
Regeneron and/or its collaborators or licensees (collectively,
“Regeneron’s Products”), and the global economy; the nature,
timing, and possible success and therapeutic applications of
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 adults and children aged
12 years and older with chronic spontaneous urticaria (“CSU”); 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 CSU (including potential approval by the U.S. Food and
Drug Administration based on the supplemental Biologics License
Application discussed in this press release), pediatric
eosinophilic esophagitis, atopic hand and foot dermatitis, chronic
inducible urticaria-cold, chronic pruritus of unknown origin,
chronic obstructive pulmonary disease with evidence of type 2
inflammation, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, allergic bronchopulmonary
aspergillosis, 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) 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
Products and Regeneron’s Product Candidates, including without
limitation Dupixent; 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; 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, Praluent® (alirocumab), and
REGEN-COV® (casirivimab and imdevimab), other litigation and other
proceedings and government investigations relating to the Company
and/or its operations, 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, 2022. 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
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Grafico Azioni Sanofi (EU:SAN)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni Sanofi (EU:SAN)
Storico
Da Lug 2023 a Lug 2024