CAMBRIDGE, Mass. and
TARRYTOWN, N.Y., June 19, 2020 /PRNewswire/ -- 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.
"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."
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.
"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."
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, Sanofi and Regeneron 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.
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 Pharmaceuticals, Inc.
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
Media Relations
Contact for Sanofi Nicolas Kressmann
Tel.: +1 (732) 532-5318
Nicolas.Kressmann@sanofi.com
|
Investor Relations
Contact for Sanofi Felix Lausher
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
|
|
|
Media Relations
Contact for Regeneron Sharon Chen Tel:
+1 (914) 847-1546 Sharon.Chen@regeneron.com
|
Investor Relations
Contact for Regeneron Mark
Hudson Tel: +1 (914)
847-3482 Mark.Hudson@regeneron.com
|
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