Dupixent® (dupilumab) approved by European Commission
for adolescents with moderate-to-severe atopic
dermatitis
- 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
PARIS and TARRYTOWN, NY – August
6, 2019 - The European Commission (EC) today extended the
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
is 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.”
Efficacy and Safety from Clinical
TrialsThe 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 DupixentDupixent 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 is being jointly developed by Sanofi
and Regeneron under a global collaboration agreement.
Dupilumab Development ProgramIn
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 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.
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.
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and ease suffering. We stand by the few who suffer from rare
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Regeneron Media Relations ContactSharon ChenTel.:
+1 (914) 847-5018Sharon.Chen@regeneron.com |
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focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by
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