Dupixent sBLA accepted for FDA priority review for
the targeted treatment of bullous pemphigoid
- If
approved, Dupixent would be the first and only targeted medicine to
treat BP in the US; FDA decision expected by June 20, 2025
-
Priority review granted based on positive pivotal results
demonstrating significant improvements in sustained disease
remission with Dupixent compared to placebo
- BP is a chronic, debilitating and
relapsing skin disease with underlying type 2 inflammation
characterized by intense itch and blisters, reddening of the skin
and painful lesions
Paris and Tarrytown, NY, February 18,
2025. The US Food and Drug Administration (FDA) has
accepted for priority review the supplemental biologics license
application (sBLA) for Dupixent (dupilumab) to treat adults with
bullous pemphigoid (BP).
The sBLA is supported by data from a pivotal
study evaluating the efficacy and safety of Dupixent in 106 adults
with moderate-to-severe BP. The primary endpoint was met, with five
times more Dupixent patients achieving sustained disease remission
compared to those on placebo. Sustained disease remission was
defined as complete clinical remission with completion of oral
corticosteroids (OCS) taper by week 16 (off OCS treatment and only
treated with Dupixent for at least 20 weeks) without relapse and no
rescue therapy use during the 36-week treatment period. The study
also showed that Dupixent significantly reduced disease severity,
itch, and use of OCS compared to placebo.
Adverse events more commonly observed with
Dupixent (in at least 3 patients) compared to placebo included
peripheral edema, arthralgia, back pain, blurred vision,
hypertension, asthma, conjunctivitis, constipation, upper
respiratory tract infection, limb injury, and insomnia.
BP is a chronic, debilitating, and relapsing
skin disease with underlying type-2 inflammation that typically
occurs in an elderly population. It is characterized by intense
itch and blisters, reddening of the skin, and painful lesions. The
blisters and rash can form over much of the body and cause the skin
to bleed and crust, resulting in patients being more prone to
infection and affecting their daily functioning. Approximately
27,000 adults in the US live with BP that is uncontrolled by
systemic corticosteroids.
Priority review is granted to regulatory
applications seeking approval for therapies that have the potential
to provide significant improvements in the treatment, diagnosis, or
prevention of serious conditions. Dupixent was previously granted
orphan drug designation by the FDA for BP, which applies to
investigational medicines intended for the treatment of rare
diseases that affect fewer than 200,000 people in the US.
The safety and efficacy of Dupixent in BP are
currently under clinical assessment and have not been evaluated by
any regulatory authority.
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 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, eosinophilic esophagitis, prurigo nodularis,
chronic spontaneous urticaria, and chronic obstructive pulmonary
disease in different age populations. More than one million
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, bullous pemphigoid, and lichen simplex chronicus. 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 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
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25 |
sandrine.guendoul@sanofi.com Evan Berland | +1 215
432 0234 | evan.berland@sanofi.comNicolas Obrist |
+ 33 6 77 21 27 55 | nicolas.obrist@sanofi.comLéo Le
Bourhis | + 33 6 75 06 43 81 |
leo.lebourhis@sanofi.comVictor Rouault | + 33 6 70
93 71 40 | victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
Larsen |+ 44 7545 513 693 |
thomas.larsen@sanofi.comAlizé Kaisserian | + 33 6
47 04 12 11 | alize.kaisserian@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comKeita Browne | + 1 781
249 1766 | keita.browne@sanofi.comNathalie Pham |
+ 33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik
Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6
80 80 89 90 | thibaud.chatelet@sanofi.com
Regeneron Media RelationsIlana
Yellen | +1 914-330-9618| ilana.yellen@regeneron.com
Regeneron Investor RelationsMark
Hudson | +1 914-847-3482 | mark.hudson@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 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, 2024. 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 except for 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); 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 adults with bullous
pemphigoid as discussed in this press release as well as chronic
pruritus of unknown origin, lichen simplex chronicus, 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; 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 (including
biosimilar versions of Regeneron’s Products); 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 on Regeneron's business; and risks associated with
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), 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), 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, 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)
과거 데이터 주식 차트
부터 1월(1) 2025 으로 2월(2) 2025
Sanofi (EU:SAN)
과거 데이터 주식 차트
부터 2월(2) 2024 으로 2월(2) 2025
