TARRYTOWN, N.Y. and
PARIS, June
28, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals,
Inc. (NASDAQ: REGN) and Sanofi today announced that the European
Medicines Agency will update the Dupixent® (dupilumab)
summary of product characteristics (SmPC) adding long-term safety
results for adults with moderate-to-severe atopic dermatitis based
on a positive opinion by the Committee for Medicinal Products for
Human Use (CHMP).
Data from a single-arm Phase 3 open label extension (OLE) trial
showed the long-term safety profile in adults with atopic
dermatitis observed up to three years was generally consistent with
what was observed in the controlled pivotal Phase 3
trials. The OLE trial assessed the long-term safety of
Dupixent 300 mg weekly in adults who had previously participated in
controlled Dupixent trials or had been screened for a Phase 3
trial. The approved Dupixent dose in adults is 300 mg every other
week.
Atopic dermatitis is a chronic inflammatory disease of the skin
that can be debilitating. Moderate-to-severe atopic dermatitis is
characterized by intense persistent itch and skin lesions that can
cover much of the body, resulting in skin dryness, cracking,
redness or darkening, crusting and oozing. Itch is one of the most
burdensome symptoms for patients. Moderate-to-severe atopic
dermatitis can also have a substantial emotional and psychosocial
impact on patients and their families, causing sleep disturbance,
anxiety, depression and feelings of isolation.
Dupixent is the only biologic approved in the European Union
(EU) for children as young as six years with severe atopic
dermatitis, as well as for adolescents and adults with
moderate-to-severe atopic dermatitis who are candidates
for systemic therapy.
Dupixent is a fully human monoclonal antibody that inhibits
the signaling of the interleukin-4 (IL-4) and interleukin-13
(IL-13) proteins. It was invented using Regeneron's proprietary
VelocImmune® technology. IL-4 and IL-13 are key
and central drivers of the type 2 inflammation that plays a major
role in atopic dermatitis, asthma, chronic rhinosinusitis with
nasal polyposis (CRSwNP) and eosinophilic esophagitis (EoE).
Dupixent is not an immunosuppressant and does not require ongoing
lab monitoring. Dupixent is currently approved in more than 60
countries, and more than 260,000 patients have been treated
globally.
About Dupixent
In the EU, Dupixent is approved
for children (6 to 11 years) with severe atopic dermatitis, as well
as for adults and adolescents 12 years and older with
moderate-to-severe atopic dermatitis who are candidates for
systemic therapy; for use in adults and adolescents 12 years
and older as an add-on maintenance treatment for severe asthma with
type 2 inflammation characterized by raised blood eosinophils
and/or raised fractional exhaled nitric oxide (FeNO), who are
inadequately controlled with high dose inhaled corticosteroid (ICS)
plus another medicinal product for maintenance treatment; and for
adults with severe CRSwNP for whom therapy with systemic
corticosteroids and/or surgery do not provide adequate disease
control.
Dupilumab Development Program
To date, dupilumab has
been studied in more than 10,000 patients across 50 clinical trials
in various chronic diseases driven 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,
including pediatric asthma (6 to 11 years of age, Phase 3), chronic
obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid
(Phase 3), prurigo nodularis (Phase 3), chronic spontaneous
urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3),
chronic rhinosinusitis without nasal polyposis (Phase 3), allergic
fungal rhinosinusitis (Phase 3), allergic bronchopulmonary
aspergillosis (Phase 3) and peanut allergy (Phase 2). 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. Dupilumab is
being jointly developed by Regeneron and Sanofi under a global
collaboration agreement.
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 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 a quarter of all original, FDA-approved fully
human monoclonal antibodies currently available. This includes
REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab),
Libtayo® (cemiplimab-rwlc), Praluent®
(alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab
and odesivimab-ebgn).
U.S. INDICATIONS
DUPIXENT is
a prescription medicine used:
- to treat people aged 6 years and older with moderate-to-severe
atopic dermatitis (eczema) 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 years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
people aged 12 years 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 12 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.
IMPORTANT SAFETY INFORMATION FOR U.S.
PATIENTS
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" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
-
- There is a pregnancy exposure registry for women who take
DUPIXENT during pregnancy to collect information about the health
of you and your baby. Your healthcare provider can enroll you or
you may enroll yourself. To get more information about the registry
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 or CRSwNP, 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 (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT
and tell your healthcare provider or get emergency help right away
if you get any of the following symptoms: breathing problems,
fever, general ill feeling, swollen lymph nodes, swelling of the
face, mouth and tongue, hives, itching, fainting, dizziness,
feeling lightheaded (low blood pressure), joint pain, or skin
rash.
- Eye problems. Tell your healthcare provider if
you have any new or worsening eye problems, including eye pain or
changes in vision.
- 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, shortness of breath, persistent fever,
chest pain, or a feeling of pins and needles or numbness of your
arms or legs.
The most common side effects by indication are as
follows:
- Atopic dermatitis: injection site reactions, eye
and eyelid inflammation, including redness, swelling, and itching,
and cold sores in your mouth or on your lips.
- Asthma: injection site reactions, pain in the
throat (oropharyngeal pain), and high count of a certain white
blood cell (eosinophilia).
- Chronic rhinosinusitis with nasal
polyposis: injection site reactions, eye and eyelid
inflammation, including redness, swelling, and itching, high count
of a certain white blood cell (eosinophilia), trouble sleeping
(insomnia), toothache, gastritis, and joint pain (arthralgia).
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. Your healthcare provider
will tell you how much DUPIXENT to inject and how often to inject
it. DUPIXENT is an injection given under the skin (subcutaneous
injection). If your healthcare provider decides that you or a
caregiver can give DUPIXENT injections, you or your caregiver
should receive training on the right way to prepare and inject
DUPIXENT. Do not try to inject DUPIXENT until you have been shown
the right way by your healthcare provider. In children 12 years of
age and older, it is recommended that DUPIXENT be administered by
or under supervision of an adult. In children younger than 12 years
of age, DUPIXENT should be given by a caregiver.
Please see accompanying full Prescribing Information
including Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 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 additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
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 (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 (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation Dupixent® (dupilumab) for
the treatment of adults with moderate-to-severe atopic dermatitis;
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 asthma, chronic obstructive pulmonary
disease with evidence of type 2 inflammation, pediatric atopic
dermatitis, eosinophilic esophagitis, bullous pemphigoid, prurigo
nodularis, chronic spontaneous urticaria, chronic inducible
urticaria-cold, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, allergic bronchopulmonary
aspergillosis, peanut allergy, 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 study discussed in this press release, on
any of the foregoing or any potential regulatory approval of
Regeneron's Products and Regeneron's Product Candidates; the
ability of Regeneron's collaborators, 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 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, Bayer, and
Teva Pharmaceutical Industries Ltd. (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, Dupixent,
Praluent® (alirocumab), and REGEN-COVTM
(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, 2020 and its Form 10-Q
for the quarterly period ended March 31,
2021. 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 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
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"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
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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
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competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
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impact that COVID-19 will have on us, our customers, suppliers,
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the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
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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
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Regeneron Contacts:
Media Relations
Hannah Kwagh
+1 (914)
847-6314
hannah.kwagh@regeneron.com
Investor Relations
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Hudson
+1 (914) 847-3482
mark.hudson@regeneron.com
Sanofi Contacts:
Media Relations
Sally
Bain
+1 (781) 264-1091
Sally.Bain@sanofi.com
Sanofi Investor Relations – Contacts
Paris
Eva Schaefer-Jansen
Arnaud Delepine
Sanofi Investor Relations – Contacts North
America
Felix Lauscher
Fara Berkowitz
Suzanne Greco
Sanofi IR main line:
+33 (0)1 53 77 45 45
investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
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SOURCE Regeneron Pharmaceuticals, Inc.