CAMBRIDGE, Mass. and
TARRYTOWN, N.Y., March 11, 2019 /PRNewswire/ -- The U.S. Food and
Drug Administration (FDA) has approved Dupixent®
(dupilumab) for adolescent patients 12 to 17 years of age with
moderate-to-severe atopic dermatitis whose disease is not
adequately controlled with topical prescription therapies, or when
those therapies are not advisable. Dupixent can be used with or
without topical corticosteroids.
"For the first time,
adolescents with uncontrolled moderate-to-severe atopic dermatitis
have an approved biologic treatment option to help control
persistent, often debilitating symptoms such as chronic itch and
widespread rash. Today's approval expands the use of Dupixent in
the U.S. to include both adults and adolescents with atopic
dermatitis or moderate-to-severe asthma," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer at Regeneron. "Given that Dupixent
targets a key pathway in type 2 inflammation, we are also
investigating it in a broad development program in patients with
other type 2 inflammatory diseases including eosinophilic
esophagitis, chronic rhinosinusitis with nasal polyps, where we
recently announced positive Phase 3 results and Priority
Review of a U.S. regulatory submission, and food and
environmental allergies."
Dupixent is a targeted biologic therapy that inhibits signaling
of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key
proteins that may play a central role in type 2 inflammation that
underlies atopic dermatitis and several other allergic
diseases.
"The approval of Dupixent for
adolescents with moderate-to-severe atopic dermatitis means that
for the first time these patients and their families, who often
help them manage this debilitating disease, will have access to a
first-of-its-kind biologic treatment that has already been used to
treat approximately 50,000 patients in the U.S.," said
John Reed, M.D., Ph.D., Head of
Research and Development at Sanofi. "Our Phase 3 data
demonstrated that Dupixent treatment significantly improved skin
lesions, reduced itching, and helped clear the skin of these
adolescent patients."
The FDA evaluated the Dupixent application under Priority
Review, which is reserved for medicines that represent potentially
significant improvements in safety or efficacy in treating serious
conditions. Dupixent was also granted Breakthrough Therapy
designation by the FDA for inadequately controlled
moderate-to-severe atopic dermatitis in adolescents. The
Breakthrough Therapy designation was created to expedite the
development and review of drugs developed for serious or
life-threatening conditions.
Dupixent helped clear the skin and reduced itching in
adolescents living with uncontrolled moderate to severe atopic
dermatitis
In the pivotal Phase 3 trial evaluating
Dupixent monotherapy in adolescent patients with uncontrolled
moderate-to-severe atopic dermatitis, the safety and efficacy
were generally consistent with that previously seen in adult
studies. At 16 weeks:
- The average improvement in the Eczema Area and Severity Index
(EASI) from baseline was approximately 66% compared to 24% for
placebo
- More than 10 times as many patients had clear or almost clear
skin with Dupixent compared to placebo: 24% of patients who
received Dupixent achieved clear or almost clear skin compared to
2% with placebo, as measured by an Investigator's Global Assessment
(IGA) score of 0 or 1, the primary endpoint of the trial
- Over five times as many patients saw overall disease
improvement of at least 75% with Dupixent compared to placebo: 42%
of patients who received Dupixent achieved 75% or greater skin
improvement compared to 8% with placebo, as measured by
EASI-75
- Over seven times as many patients experienced significantly
reduced itch with Dupixent compared to placebo: 37% of patients who
received Dupixent achieved a clinically meaningful improvement in
itch of at least four points on the Peak Pruritus Numerical Rating
Scale (NRS) compared to 5% with placebo
Dupixent has been studied in more than 7,000 patients 12 years
and older in over 30 clinical trials. The safety profile of
Dupixent in the adolescent trial was similar to the safety profile
from trials in adults with atopic dermatitis, and consistent
through 52 weeks. The most common adverse events were
injection-site reactions, eye and eyelid inflammation including
redness, swelling and itching, pain in the throat (oropharyngeal
pain) and cold sores in the mouth or on the lips.
Atopic dermatitis, a form of eczema, is a chronic inflammatory
disease with symptoms often appearing as a rash on the skin.
Moderate-to-severe atopic dermatitis is characterized by rashes
that can potentially cover much of the body, and can include
intense, persistent itching, skin lesions and skin dryness,
cracking, redness, crusting and oozing. Itch is one of the most
burdensome symptoms for patients and can be debilitating.
Dupixent comes in two doses (200 mg and 300 mg), each as a
pre-filled syringe. Dupixent is intended for injection under the
skin (subcutaneous injection) and is given every other week
following an initial loading dose. It can be given in a clinic or,
for convenience, at home by self-administration after training by a
healthcare professional.
Dupixent is also approved in the U.S. for the treatment of
adult patients 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; and for
use 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. 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.
Sanofi and Regeneron 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.
Outside of the U.S., Dupixent is also approved in a number of
other countries for use in certain adults with moderate-to-severe
atopic dermatitis. Dupixent is currently under regulatory review
for adolescents with moderate-to-severe atopic dermatitis in
several countries, including Japan, and in the European Union (EU).
Dupilumab is being developed jointly by Sanofi and Regeneron as
part of a global collaboration agreement.
Dupilumab Development Program
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 chronic rhinosinusitis with nasal polyps
(Phase 3 completed), pediatric (6 to 11 years of age) atopic
dermatitis (Phase 3), pediatric (6 months to 5 years of age) atopic
dermatitis (Phase 2/3), pediatric (6 to 11 years of age) asthma
(Phase 3), eosinophilic esophagitis (Phase 2/3), and food and
environmental allergies (Phase 2). A future trial is planned
for chronic obstructive pulmonary disease. Dupilumab is also being
studied in combination with REGN3500, which targets IL-33. These
potential uses are investigational and the safety and efficacy have
not been evaluated by any regulatory authority.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat people 12 years of age 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 12
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.
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 (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. 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 adolescents 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.
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 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, 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
Sanofi Media
Relations Contact Ashleigh Koss
Tel.: +1 (908) 981-8745
Ashleigh.Koss@sanofi.com
Regeneron Media Relations
Contact Sharon
Chen Tel.: +1 (914)
847-5018 Sharon.Chen@regeneron.com
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Sanofi Investor
Relations Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Regeneron Investor
Relations Contact Mark
Hudson Tel.: +1 (914)
847-3482 Mark.Hudson@regeneron.com
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