TARRYTOWN, N.Y. and
PARIS, Aug.
6, 2019 /PRNewswire/ --
Only biologic approved in the European Union for patients
aged 12 and above with moderate-to-severe atopic dermatitis
Approval is based on Phase 3 trial results showing Dupixent
significantly improved disease extent and severity, skin clearance,
and itch intensity, as well as sleep and health-related quality of
life
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the European Commission (EC) extended
marketing authorization for Dupixent® (dupilumab) in the
European Union (EU) to include adolescents 12 to 17 years of age
with moderate-to-severe atopic dermatitis who are candidates for
systemic therapy. Dupixent is now the first biologic medicine
approved in the EU to treat these patients.
"Moderate-to-severe atopic dermatitis can affect many aspects of
an adolescent's life, including their physical and emotional
well-being," said Christine Janus,
Chief Executive Officer of the International Alliance of
Dermatology Patient Organizations. "This disease places an immense
burden not only on the young people living with it but also the
family members who care for them. We welcome the addition of new
treatment options to help adolescents control and manage an often
debilitating disease."
Atopic dermatitis, the most common form of eczema, is a chronic
inflammatory disease. In its moderate-to-severe form, it 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. Inadequately
controlled atopic dermatitis can have a physical, emotional and
psychosocial impact, causing sleep disturbance, symptoms of anxiety
and depression, and feelings of isolation. Despite standard-of-care
therapy, there continues to be an unmet need for many adolescents
with moderate-to-severe atopic dermatitis who often have
uncontrolled, persistent symptoms.
"Adolescents with moderate-to-severe atopic dermatitis in the EU
now have an approved biologic medicine that can significantly
control persistent, debilitating symptoms like itch and skin
lesions, as well as improve sleep, which is particularly critical
during these formative years," said George
D. Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron. "Today's approval also provides these young
patients with a treatment option that addresses the type 2
inflammation that underlies atopic dermatitis. In addition to its
approved uses in atopic dermatitis and asthma in the EU, we
continue to investigate Dupixent in a broad range of patients with
other type 2 inflammatory diseases."
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins. 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, as well as asthma and chronic
rhinosinusitis with nasal polyposis (CRSwNP, currently under review
in the EU).
"Adolescents with inadequately controlled moderate-to-severe
atopic dermatitis face a certain set of challenges that can have a
lasting impact on their lives. The physical and psychological
symptoms of moderate-to-severe atopic dermatitis can prevent
adolescents from fully participating in activities with their
peers, including school, sports and hobbies, and can often place a
serious burden on family members," said John Reed, M.D., Ph.D., Head of Research and
Development at Sanofi. "From our Phase 3 trials, we know Dupixent
significantly reduced itch, helped clear the skin, and improved
health-related quality of life outcomes for adolescents at this
critical period of their lives."
The EC approval is based on clinical data from the LIBERTY AD
program, including a pivotal Phase 3 trial and an open-label
extension trial evaluating the efficacy and safety of Dupixent in
adolescents with uncontrolled moderate-to-severe atopic dermatitis.
Key data points from the pivotal trials at 16 weeks include:
- More than five times as many Dupixent patients experienced at
least 75% improvement in disease extent and severity compared to
placebo: 42% of patients who received Dupixent achieved 75% or
greater skin improvement compared to 8% with placebo, as measured
by the Eczema Area and Severity Index (EASI-75), the co-primary
endpoint of the trial.
- More than 10 times as many Dupixent patients had clear or
almost clear skin 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 co-primary endpoint of the trial.
- Dupixent patients experienced a 66% average improvement in the
EASI score of skin inflammation from baseline compared to 24% for
placebo.
- More than seven times as many Dupixent patients experienced
significantly less itch 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.
- More than three times as many Dupixent patients experienced
significant improvements in health-related quality of life compared
to placebo: 61% of patients who received Dupixent achieved a
clinically meaningful improvement in quality of life of at least
six points on the Children's Dermatology Life Quality Index (CDLQI)
compared to 20% with placebo.
- More than six times as many Dupixent patients reported
significant improvements in disease severity compared to placebo:
63% of patients who received Dupixent reported a clinically
meaningful improvement in disease severity of at least six points
on the Patient Oriented Eczema Measure (POEM), which is a composite
measure that includes sleep, compared to 10% with placebo.
Data from the open-label extension trial showed that the
clinical benefit of Dupixent at week 16 was sustained through week
52. The safety profile of Dupixent in adolescent trials was similar
to the safety profile from trials in adults with atopic dermatitis,
and consistent through 52 weeks as observed in the open-label
extension trial. The most common adverse events were injection site
reactions, eye and eyelid inflammation including redness, swelling
and itching, and cold sores.
There is no requirement for initial laboratory testing or
ongoing laboratory monitoring for patients taking
Dupixent.
About Dupixent
Dupixent comes in two doses (200 mg and
300 mg), each as a pre-filled syringe, and the dose is weight-based
(<60 kilograms [kgs] or >60 kgs) in adolescents with atopic
dermatitis. Dupixent is intended for injection under the skin
(subcutaneous injection) and is given every other week following an
initial dose (400 mg and 600 mg, respectively). Dupixent can be
given in a clinic or at home by self-administration after training
by a healthcare professional.
This approval in the EU expands the indication for Dupixent,
which is approved for use in adults 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.
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.
for use with other medicines to treat CRSwNP in adults whose
disease is not controlled and is currently under regulatory review
for patients with CRSwNP in the EU.
Dupilumab Development Program
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 and atopic dermatitis
(6 to 11 years of age, Phase 3), pediatric atopic dermatitis (6
months to 5 years of age, Phase 2/3), eosinophilic esophagitis
(Phase 2/3), chronic obstructive pulmonary disease (Phase 3) and
food and environmental allergies (Phase 2). Dupilumab is also being
studied in combination with REGN3500 (SAR440340), which targets IL-33. These potential
uses are investigational and the safety and efficacy have not been
evaluated by any regulatory authority. Dupilumab and REGN3500 were
invented using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully human antibodies, and are being jointly developed by
Regeneron and Sanofi under a global collaboration agreement.
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.
- with other medicines to treat chronic rhinosinusitis with nasal
polyposis 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 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. 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. 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.
Please see accompanying 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 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, infectious diseases, pain 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
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
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(dupilumab) Injection; the likelihood, timing, and scope of
possible regulatory approval and commercial launch of Regeneron's
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and pediatric atopic dermatitis, eosinophilic esophagitis, chronic
obstructive pulmonary disease, food and environmental allergies,
and other potential indications (as well as in combination with
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the ability of Regeneron to meet any of its financial projections
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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
EYLEA® (aflibercept) Injection, Dupixent, and Praluent®
(alirocumab) Injection, the ultimate outcome of any such
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Regeneron
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Investor
Relations
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Sharon.Chen@regeneron.com
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SOURCE Regeneron Pharmaceuticals, Inc.