TARRYTOWN, N.Y. and PARIS,
Oct. 16, 2020 /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 for Dupixent® (dupilumab), recommending to
extend the approval in the European Union (EU) to include children
aged 6 to 11 years with severe atopic dermatitis who are candidates
for systemic therapy.
Dupixent is the first and only biologic approved for the
treatment of uncontrolled moderate-to-severe atopic dermatitis for
people 12 years of age and older in the EU and 6 years of age and
older in the U.S. Dupixent is also approved in the EU for certain
patients with severe asthma and severe chronic rhinosinusitis with
nasal polyps (CRSwNP), two other type 2 inflammatory diseases.
The European Commission is expected to announce a final decision
on the Dupixent application in the coming months. The positive CHMP
opinion is supported by data that include pivotal Phase 3 results
on the efficacy and safety of Dupixent combined with topical
corticosteroids (TCS) in children aged 6 to 11 years with severe
atopic dermatitis that is uncontrolled on topical prescription
therapies. In the trial, children treated with Dupixent and TCS
experienced significantly improved measures of overall disease
severity (Eczema Area and Severity Index), skin clearance, itch and
health-related quality of life measures, compared to TCS alone.
Adverse events more commonly observed with Dupixent included
conjunctivitis, nasopharyngitis and injection site reactions. These
data are consistent with the well-established efficacy and safety
profile of Dupixent observed across adult and adolescent atopic
dermatitis trials. The use of Dupixent in children aged 6 to 11
years is investigational and its efficacy and safety have not yet
been fully evaluated in the EU.
Atopic dermatitis is a chronic inflammatory disease of the skin
that can be debilitating. The current standard of care for children
with severe atopic dermatitis in Europe is limited to TCS, leaving those with
poorly controlled disease to cope with intense, unrelenting itch
and skin lesions that cover much of the body resulting in skin
cracking, redness or darkening, crusting and oozing. In addition,
uncontrolled severe atopic dermatitis can have a significant
emotional and psychosocial impact, causing sleep disturbance,
symptoms of anxiety and depression, and feelings of isolation for
children and their families.
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins, and is not an immunosuppressant. Data from Dupixent
clinical trials have shown that IL-4 and IL-13 are key drivers of
the type 2 inflammation that plays a major role in atopic
dermatitis, asthma and CRSwNP. Dupixent is currently approved in
more than 60 countries, and more than 170,000 patients have been
treated globally.
About Dupixent
Dupixent is currently
approved in the EU for use in adults and adolescents 12 years and
older with moderate-to-severe atopic dermatitis who are candidates
for systemic therapy. It is also approved in the EU for 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. Dupixent is also approved in the EU for adults with
severe CRSwNP for whom therapy with systemic corticosteroids and/or
surgery do not provide adequate disease control.
Outside of the EU, Dupixent is approved for use in specific
patients with moderate-to-severe atopic dermatitis and certain
patients with asthma in a number of other countries around the
world, including the U.S. and Japan. Dupixent is also approved in the U.S.
and Japan to treat certain adults
with severe CRSwNP.
Dupilumab Development Program
To date, dupilumab
has been studied in more than 10,000 patients aged 6 and
up across 50 clinical trials in various chronic diseases driven by
type 2 inflammation.
In addition to the currently approved indications, Regeneron and
Sanofi are also 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),
pediatric atopic dermatitis (6 months to 5 years of age, Phase
2/3), eosinophilic esophagitis (Phase 3), chronic obstructive
pulmonary disease (Phase 3), bullous pemphigoid (Phase 3), prurigo
nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), and
food and environmental allergies (Phase 2). These potential uses
are investigational, and the safety and efficacy of dupilumab in
these conditions have not been evaluated by any regulatory
authority. Dupilumab is being jointly developed by Regeneron and
Sanofi under a global collaboration agreement.
Dupilumab was invented using Regeneron's
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been used
to create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Zaire ebolavirus infection, which is
approved by the FDA, and to create REGN-COV2, a potentially
preventative and therapeutic investigational medicine for COVID-19
that was recently submitted to the FDA for an Emergency Use
Authorization (EUA).
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
indications 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 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 eight FDA-approved treatments and numerous product candidates in
development, 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, 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 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
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 European Commission's decision regarding the
application to extend Dupixent's approval in the European Union to
include children aged 6 to 11 years with severe atopic dermatitis
who are candidates for systemic therapy; uncertainty of market
acceptance and commercial success of Regeneron's Products and
product candidates and the impact of studies (whether conducted by
Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products (such as Dupixent) and
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, including
possible regulatory approval of Dupixent for children aged 6 to 11
years with severe atopic dermatitis who are candidates for systemic
therapy in the European Union discussed in this press
release and possible regulatory approval of Dupixent in other
jurisdictions and indications (such as for the treatment of
pediatric asthma, pediatric atopic dermatitis, eosinophilic
esophagitis, chronic obstructive pulmonary disease, bullous
pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food
and environmental allergies, and other potential indications);
safety issues resulting from the administration of Regeneron's
Products (such as Dupixent) and product candidates in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and 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 (such as Dupixent) and 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 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;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and 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 product candidates; 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 or
collaboration 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, and Praluent® (alirocumab)), 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, 2019 and its Form 10-Q for the
quarterly period ended June 30,
2020. 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 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
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, 2019. 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
|
Investor
Relations
|
Hannah
Kwagh
|
Mark
Hudson
|
Tel: +1 (914) 847
6314
|
Tel.: +1 (914) 847
3482
|
Hannah.Kwagh@regeneron.com
|
Mark.Hudson@regeneron.com
|
|
|
Sanofi
Contacts:
|
|
|
|
Media
Relations
|
Investor
Relations
|
Sally
Bain
|
Sanofi Investor
Relations – Contacts Paris
|
Tel.: +1 (781)
264-1091
|
Eva
Schaefer-Jansen
|
Sally.Bain@sanofi.com
|
Arnaud
Delepine
|
|
Yvonne
Naughton
|
|
|
|
Sanofi Investor
Relations – Contacts North
America
|
|
Felix
Lauscher
|
|
Fara
Berkowitz
|
|
Suzanne
Greco
|
|
|
|
Sanofi IR main
line:
|
|
Tel.: +33 (0)1 53 77
45 45
|
|
ir@sanofi.com
|
|
https://www.sanofi.com/en/investors/contact
|
View original
content:http://www.prnewswire.com/news-releases/chmp-recommends-approval-of-dupixent-dupilumab-for-children-aged-6-to-11-years-with-severe-atopic-dermatitis-301153966.html
SOURCE Regeneron Pharmaceuticals, Inc.