If approved, Dupixent would be the first and only targeted
medicine specifically indicated for people aged 12 years and older
with eosinophilic esophagitis in the European Union
In the U.S., Dupixent is currently the only medicine
indicated to treat eosinophilic esophagitis
Approval recommendation based on pivotal trial data
demonstrating patients on Dupixent 300 mg weekly experienced
significantly improved ability to swallow and achieved histological
disease remission compared to placebo
In the European Union, about 50,000 adults and adolescents
live with severe uncontrolled eosinophilic esophagitis
TARRYTOWN, N.Y. and PARIS, Dec. 16,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that the European
Medicines Agency's Committee for Medicinal Products for Human Use
(CHMP) has adopted a positive opinion, recommending the approval of
Dupixent® (dupilumab) in the European Union (EU) to
treat adults and adolescents with eosinophilic esophagitis (EoE).
This positive opinion covers those who are 12 years and older,
weighing at least 40 kg, and inadequately controlled by, are
intolerant to or who are not candidates for conventional medicinal
therapy. The European Commission is expected to announce a final
decision on the Dupixent application in the coming months. In
May 2022, Dupixent 300 mg weekly was
approved by the U.S. Food and Drug Administration for the
treatment of patients aged 12 years and older, weighing at least 40
kg.
EoE is a chronic, progressive inflammatory disease that damages
the esophagus and prevents it from working properly. The results
seen with Dupixent in adults and adolescents with EoE demonstrate
that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and
central drivers of the type 2 inflammation underlying this disease.
For people with EoE, swallowing even small amounts of food can be a
painful and worrisome choking experience. They are often left to
contend with the frustration and anxiety of a constantly evolving
list of foods to avoid, a poor quality of life and a higher risk of
depression. In cases where EoE causes the esophagus to narrow,
forced and potentially painful dilation (physical expansion) of the
esophagus may be needed. In severe cases, a feeding tube may be the
only option to ensure proper caloric intake and adequate
nutrition.
The positive CHMP opinion is supported by 52-week data from a
Phase 3 trial consisting of three parts – Part A and Part
B investigated Dupixent 300 mg weekly compared to placebo for
24 weeks, and Part C observed patients from Parts A and B, all of
whom were on Dupixent, having continued on or switched to Dupixent
for an additional 28 weeks. The results demonstrated
Dupixent-treated patients experienced improvements in their ability
to swallow as early as four weeks, as well as histological disease
remission, improvements in abnormal endoscopic findings of the
esophagus and cellular improvements at 24 weeks compared to
placebo, with outcomes maintained up to one year. The safety
results of the trial were generally consistent with the known
safety profile of Dupixent in its approved indications. Adverse
events more commonly observed with Dupixent compared to placebo
included infections.
The use of Dupixent in adults and adolescents with EoE is
investigational in the EU and is not yet approved.
About Dupixent
Dupixent, which was invented using
Regeneron's proprietary VelocImmune® technology,
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) and prurigo
nodularis, as well as investigational diseases such as EoE in the
EU.
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.
About Regeneron's
VelocImmune Technology
Regeneron's
VelocImmune technology utilizes a proprietary genetically
engineered mouse platform endowed with a genetically humanized
immune system to produce optimized fully human antibodies. When
Regeneron's co-Founder, President and Chief Scientific Officer
George D. Yancopoulos was a graduate
student with his mentor Frederick W.
Alt in 1985, they were the first to envision making
such a genetically humanized mouse, and Regeneron has spent decades
inventing and developing VelocImmune and related
VelociSuite® technologies. Dr. Yancopoulos and
his team have used VelocImmune technology to create approximately
one in five of all original, FDA-approved or authorized fully human
monoclonal antibodies. This includes REGEN-COV®
(casirivimab and imdevimab), Dupixent, Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab),
Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb® (atoltivimab, maftivimab
and odesivimab-ebgn).
Dupilumab Development Program
Dupilumab 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, Regeneron and
Sanofi 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, hand and foot atopic dermatitis,
chronic inducible urticaria-cold, chronic spontaneous urticaria,
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.
U.S. INDICATIONS
DUPIXENT is
a prescription medicine used:
- to treat adults and children 6 months of age and older with
moderate-to-severe eczema (atopic dermatitis or AD) that is not
well controlled with prescription therapies used on the skin
(topical), or who cannot use topical therapies. DUPIXENT can be
used with or without topical corticosteroids. It is not known if
DUPIXENT is safe and effective in children with atopic dermatitis
under 6 months of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
adults and children 6 years of age and older whose asthma is not
controlled with their current asthma medicines. DUPIXENT helps
prevent severe asthma attacks (exacerbations) and can improve your
breathing. DUPIXENT may also help reduce the amount of oral
corticosteroids you need while preventing severe asthma attacks and
improving your breathing. DUPIXENT is not used to treat sudden
breathing problems. It is not known if DUPIXENT is safe and
effective in children with asthma under 6 years of age.
- with other medicines for the maintenance treatment of chronic
rhinosinusitis with nasal polyposis (CRSwNP) in adults whose
disease is not controlled. It is not known if DUPIXENT is safe and
effective in children with chronic rhinosinusitis with nasal
polyposis under 18 years of age.
- to treat adults and children 12 years of age and older, who
weigh at least 88 pounds (40 kg), with eosinophilic esophagitis
(EoE). It is not known if DUPIXENT is safe and effective in
children with eosinophilic esophagitis under 12 years of age and
who weigh at least 88 pounds (40 kg).
- to treat adults with prurigo nodularis (PN). It is not known if
DUPIXENT is safe and effective in children with prurigo nodularis
under 18 years of age.
IMPORTANT SAFETY
INFORMATION
Do not use if
you are allergic to dupilumab or to any of
the ingredients in DUPIXENT®.
Before
using DUPIXENT, tell your healthcare provider about all your medical conditions, including if
you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" right before and during treatment with
DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
-
- A pregnancy registry for women who take DUPIXENT during
pregnancy collects information about the health of you and your
baby. To enroll or get more information call 1-877-311-8972 or go
to https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the
medicines you take, including prescription and over-the-
counter medicines, vitamins, and herbal
supplements.
Especially tell your healthcare provider if you are
taking oral, topical, or inhaled corticosteroid medicines; have
asthma and use an asthma medicine; or have atopic dermatitis,
chronic rhinosinusitis with nasal polyposis, eosinophilic
esophagitis, or prurigo nodularis and also have asthma. Do
not change or stop your corticosteroid medicine or other asthma
medicine without talking to your healthcare provider. This may
cause other symptoms that were controlled by the corticosteroid
medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions.
DUPIXENT can cause allergic reactions that can sometimes be
severe. Stop using DUPIXENT and tell your healthcare provider
or get emergency help right away if you get any of the following
signs or symptoms: breathing problems or wheezing, swelling of the
face, lips, mouth, tongue or throat, fainting, dizziness, feeling
lightheaded, fast pulse, fever, hives, joint pain, general ill
feeling, itching, skin rash, swollen lymph nodes, nausea or
vomiting, or cramps in your stomach-area.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision, such as blurred vision. Your healthcare provider may send
you to an ophthalmologist for an exam if needed.
- Inflammation of your blood vessels.
Rarely, this can happen in people with asthma who receive DUPIXENT.
This may happen in people who also take a steroid medicine by mouth
that is being stopped or the dose is being lowered. It is not known
whether this is caused by DUPIXENT. Tell your healthcare provider
right away if you have: rash, chest pain, worsening shortness of
breath, a feeling of pins and needles or numbness of your arms or
legs, or persistent fever.
- Joint aches and pain. Some people who use DUPIXENT have
had trouble walking or moving due to their joint symptoms, and in
some cases needed to be hospitalized. Tell your healthcare provider
about any new or worsening joint symptoms. Your healthcare provider
may stop DUPIXENT if you develop joint symptoms.
The most common side effects include:
- Eczema: injection site reactions, eye and eyelid
inflammation, including redness, swelling, and itching, sometimes
with blurred vision, cold sores in your mouth or on your lips, and
high count of a certain white blood cell (eosinophilia).
- Asthma: injection site reactions, high count of a
certain white blood cell (eosinophilia), pain in the throat
(oropharyngeal pain), and parasitic (helminth) infections.
- Chronic Rhinosinusitis
with Nasal Polyposis: injection site reactions, eye and eyelid
inflammation, including redness, swelling, and itching, sometimes
with blurred vision, high count of a certain white blood cell
(eosinophilia), gastritis, joint pain (arthralgia), trouble
sleeping (insomnia), and toothache.
- Eosinophilic Esophagitis: injection site reactions,
upper respiratory tract infections, cold sores in your mouth or on
your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid inflammation,
including redness, swelling, and itching, sometimes with blurred
vision, herpes virus infections, common cold symptoms
(nasopharyngitis), dizziness, muscle pain, and diarrhea.
Tell your healthcare provider if
you have any side
effect that bothers you or that does not go away.
These are not all the possible side
effects of DUPIXENT. Call
your doctor for medical advice about side
effects. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed by your healthcare provider.
It's an injection given under the skin (subcutaneous injection).
Your healthcare provider will decide if you or your caregiver can
inject DUPIXENT. Do not try to prepare and inject
DUPIXENT until you or your caregiver have been trained by your
healthcare provider. In children 12 years of age and older, it's
recommended DUPIXENT be administered by or under supervision of an
adult. In children 6 months to less than 12 years of age, DUPIXENT
should be given by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
About Regeneron
Regeneron is a leading biotechnology company that invents, develops
and commercializes life-transforming medicines for people with
serious diseases. Founded and led for nearly 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 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 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.
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);
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 for the treatment of adults and adolescents
with eosinophilic esophagitis ("EoE"); 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 and
Regeneron's Product Candidates; 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, hand
and foot atopic dermatitis, chronic inducible urticaria-cold,
chronic spontaneous urticaria, 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, 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, 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, 2021 and its Form 10-Q for the
quarterly period ended September 30,
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).
Sanofi Disclaimers or 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 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. Any material effect of COVID-19 on any of the
foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. 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, 2021. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron
Contacts:
Media
Relations
Sharon
Chen
Tel: +1
914-847-1546
Sharon.Chen@regeneron.com
|
Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443
Vesna.Tosic@regeneron.com
|
Sanofi
Contacts:
Media
Relations
Sally
Bain
Tel: +1
617-834-6026
Sally.Bain@sanofi.com
|
Investor
Relations
Eva
Schaefer-Jansen
Tel: +33 7 86 80 56
39
eva.schaefer-jansen@sanofi.com
Arnaud
Delepine
Tel: +33 (0)6 73 69 36
93
arnaud.delepine@sanofi.com
Corentine
Driancourt
Tel: +33 (0)6 40 56
92
corentine.driancourt@sanofi.com
Felix
Lauscher
Tel: +1
908-612-7239
felix.lauscher@sanofi.com
Priya
Nanduri
Tel: +1
617-764-6418
priya.nanduri@sanofi.com
Nathalie
Pham
Tel: +33 (0)7 85 93 30
17
nathalie.pham@sanofi.com
|
View original
content:https://www.prnewswire.com/news-releases/dupixent-dupilumab-recommended-for-eu-approval-by-the-chmp-for-the-treatment-of-eosinophilic-esophagitis-301705159.html
SOURCE Regeneron Pharmaceuticals, Inc.