PARIS and TARRYTOWN, N.Y., Nov.
6, 2018 /PRNewswire/ -- The U.S. Food and Drug
Administration (FDA) has accepted for Priority Review the
supplemental Biologics License Application (sBLA) for
Dupixent® (dupilumab) in adolescent patients 12 to 17
years of age with moderate-to-severe atopic dermatitis, whose
disease was inadequately controlled with topical therapies or for
whom topical treatment was medically inadvisable. Currently, there
are no FDA-approved systemic biologic medicines to treat
adolescents with moderate-to-severe atopic dermatitis. The target
action date for the FDA decision is March
11, 2019.
The sBLA is supported by data from a pivotal Phase 3 trial
evaluating the efficacy and safety of Dupixent monotherapy in
adolescent patients with moderate-to-severe atopic dermatitis,
which were presented at the European Academy of Dermatology and
Venereology in September 2018.
Dupixent works by inhibiting interleukin-4 and interleukin-13
(IL-4 and IL-13) signaling, which is one of the important
contributors to Type 2 inflammation, a systemic response known to
play a role in moderate-to-severe atopic dermatitis.
Dupixent is currently approved in the U.S. as a treatment for
adults with moderate-to-severe atopic dermatitis whose disease is
not adequately controlled with topical prescription therapies or
when those therapies are not advisable; and as add-on maintenance
treatment for patients 12 years and older with moderate-to-severe
asthma with an eosinophilic phenotype or with oral
corticosteroid-dependent asthma. In 2016, the FDA granted
Breakthrough Therapy designation for Dupixent for the treatment of
moderate-to-severe (adolescents 12 to 17 years of age) and severe
(children 6 months to 11 years of age) atopic dermatitis not well
controlled on topical prescription medications.
Dupixent is also approved for use in certain adult patients with
moderate-to-severe atopic dermatitis in countries of the European
Union, and other countries including Canada and Japan. In the U.S., more than 60,000 adult
patients with atopic dermatitis have been prescribed Dupixent to
date.
The safety and efficacy of Dupixent in adolescents with atopic
dermatitis have not been fully evaluated by any regulatory
authority.
Dupilumab ongoing development program
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 (6
months to 11 years of age) atopic dermatitis (Phase 3), pediatric
asthma (Phase 3), chronic rhinosinusitis with nasal polyps (Phase
3), eosinophilic esophagitis (Phase 3), grass allergy (Phase 2) and
peanut allergy (Phase 2). A future trial is planned for chronic
obstructive pulmonary disease. Dupixent is also being studied in
combination with REGN-3500, which targets IL-33. These potential
uses are investigational and the safety and efficacy have not been
evaluated by any regulatory authority. Dupilumab is being jointly
developed by Sanofi and Regeneron under a global collaboration
agreement.
IMPORTANT SAFETY INFORMATION AND INDICATIONS
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 (if you also have atopic dermatitis)
- have a parasitic (helminth) infection
- are taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- 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.
- 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. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
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. If you have atopic dermatitis, tell your
healthcare provider if you have any new or worsening eye problems,
including eye pain or changes in vision.
- Inflammation in 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 injection site
reactions, pain in the throat (oropharyngeal pain) and cold sores
in your mouth or on your lips. Eye and eyelid inflammation,
including redness, swelling and itching have been seen in patients
who have atopic dermatitis.
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. 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 adolescents with asthma 12 years of age and
older, it is recommended that DUPIXENT be administered by or under
supervision of an adult.
Please see accompanying full Prescribing Information
including Patient Information.
INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults 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 18 years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe 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.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for 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 disease, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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 Ashleigh Koss
Tel.: +1 (908) 981-8745
Ashleigh.Koss@sanofi.com
Regeneron Media Relations Contact
Sarah Cornhill
Tel.: +1 (914) 847-5018
Sarah.Cornhill@regeneron.com
|
Investor Relations
Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Regeneron Investor Relations Contact Manisha Narasimhan,
Ph.D.
Tel: +1 914-847-5126 Manisha.narasimhan@regeneron.com
|
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