TARRYTOWN, N.Y. and
CAMBRIDGE, Mass., June 19, 2020 /PRNewswire/ --
Single-dose (300 mg) pre-filled pen provides additional
administration option to adults and adolescents who are prescribed
Dupixent
300 mg pre-filled pen expected to be available third quarter
of 2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
approved a 300 mg single-dose pre-filled pen for
Dupixent® (dupilumab). The pre-filled pen is approved
for all Dupixent indications in patients aged 12 years and older,
which includes use in certain patients with atopic dermatitis,
asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP),
for at-home administration. This new pre-filled pen will
provide patients with a more convenient option for
administering Dupixent.
"Chronic type 2 inflammatory diseases such as atopic dermatitis,
asthma and chronic rhinosinusitis with nasal polyps can be
incredibly complex to manage, leaving patients burdened and
apprehensive about their treatment options," said George D. Yancopoulos, M.D., Ph.D., Co-founder,
President and Chief Scientific Officer at Regeneron. "The Dupixent
pre-filled pen was specifically designed to provide patients with
an easy-to-use, convenient option so they can feel more comfortable
administering their injections."
The 300 mg pre-filled pen is expected to be available in the
U.S. in the third quarter of 2020. The pre-filled pen features a
hidden needle and single-press auto-injection, along with visual
and audio feedback to help with administration. Regeneron and
Sanofi are working with the FDA to provide additional data they
require to complete their review of the 200 mg pre-filled pen. The
pre-filled syringe continues to be available in both 200 mg and 300
mg doses for use in a clinic or at home by self-administration.
Both methods of administration require training by a healthcare
professional.
"We know that administering or receiving an injection,
especially for a medicine that patients need to receive regularly,
can seem daunting for patients or their parents or caregivers,"
said Bill Sibold, Executive Vice
President and Head of Sanofi Genzyme. "The Dupixent pre-filled pen
was developed based on patient input and offers the latest
technology, including visual and audio cues, to help provide
support when taking this medicine."
Regeneron and Sanofi are committed to helping patients in the
U.S. who are prescribed Dupixent gain access to the medicine and
receive the support they may need with the DUPIXENT
MyWay® program. For more information, please call
1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.
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. Across all approved indications
globally, more than 150,000 patients have been treated with
Dupixent.
About Dupixent
Dupixent is approved in the U.S. to
treat patients aged 6 years and older with moderate-to-severe
atopic dermatitis that is not well controlled with prescription
therapies used on the skin (topical), or who cannot use topical
therapies; for use with other asthma medicines for the maintenance
treatment of moderate-to-severe eosinophilic or oral steroid
dependent asthma in patients aged 12 years and older whose asthma
is not controlled with their current asthma medicines; and for use
with other medicines for the maintenance treatment of CRSwNP in
adults whose disease is not controlled. In adolescents 12 years of
age or older, it is recommended that Dupixent be administered by or
under the supervision of an adult. In children younger than 12
years of age, Dupixent should be administered by a caregiver.
Outside of the U.S., Dupixent is approved for specific patients
with moderate-to-severe atopic dermatitis and certain patients with
asthma in a number of other countries around the world, including
the EU and Japan. Dupixent is also
approved in the EU and Japan to
treat certain adults with severe CRSwNP. The 200 mg and 300 mg
pre-filled pens are currently approved in the EU.
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, Regeneron and Sanofi are also studying dupilumab in a
broad range of clinical development programs for diseases driven by
allergic and other type 2 inflammation, 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 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 proprietary
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 Ebola virus
infection, which is currently under review by the FDA, and is now
being used in efforts to create prophylactic and treatment
medicines for COVID-19.
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 include:
- 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 seven
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, 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);
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 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, such as dupilumab 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; unforeseen 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 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
(such as Dupixent) 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 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 lead to advancement of product candidates to
clinical trials or therapeutic applications; 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 without
any further product success; 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 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 March
31, 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
|
Sharon
Chen
|
|
Mark
Hudson
|
Tel: +1 (914)
847-1546
|
|
Tel: +1 (914)
847-3482
|
Sharon.Chen@regeneron.com
|
|
Mark.Hudson@regeneron.com
|
|
|
|
Sanofi
Contacts:
|
|
|
|
|
|
Media
Relations
|
|
Investor
Relations
|
Nicolas
Kressmann
|
|
Felix
Lauscher
|
Tel.: +1 (732)
532-5318
|
|
Tel: +33 (0)1 53 77
45 45
|
Nicolas.Kressmann@sanofi.com
|
|
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.