Dupixent® (dupilumab) approved by European Commission as first and
only biologic medicine for children aged 6 to 11 years with severe
atopic dermatitis
Dupixent® (dupilumab) approved by European Commission as
first and only biologic medicine for children aged 6 to 11 years
with severe atopic dermatitis
- Pivotal trial showed more than four times as many children
achieved itch reduction and more than three times as many children
achieved clear or almost clear skin with Dupixent plus topical
corticosteroids (TCS) compared to TCS alone
- Nearly three in four children achieved a 75% improvement in
disease extent and severity, with an average improvement of
approximately 80%
- Approximately 80% of children experienced clinically meaningful
improvements in a composite of health-related quality of life
measures that include sleep, school, emotional well-being and
relationships
- Expanded approval of Dupixent for these children reinforces
well-established, long-term safety profile
PARIS and TARRYTOWN, N.Y. – November 30,
2020 – The European Commission (EC) has extended the
marketing authorization for Dupixent® (dupilumab) in the European
Union (EU) to include children 6 to 11 years of age with severe
atopic dermatitis who are candidates for systemic therapy. Dupixent
is the only systemic medicine approved in the EU to treat these
patients.
"As the parent of a child with atopic
dermatitis, and someone who works with families impacted by this
condition daily, I’ve seen first-hand the enormous physical and
mental health burden of this disease, and the toll it can take on
the entire family,” said Korey Capozza, MPH, Founder and Executive
Director of Global Parents for Eczema Research (GPER). “Young
children with severe atopic dermatitis currently have few treatment
choices and significant unmet needs. We welcome the addition
of new medicines for these underserved patients."
Atopic dermatitis is a chronic inflammatory
disease of the skin that can be debilitating, and severe disease
can significantly impact many aspects of life for both children and
their families. The current standard of care for children with
severe atopic dermatitis in Europe is limited to topical
treatments, leaving those with poorly controlled disease to cope
with intense, unrelenting itch and skin lesions that can cover much
of the body, resulting in skin cracking, redness or darkening,
crusting and oozing. In addition, uncontrolled severe atopic
dermatitis can have a substantial emotional and psychosocial
impact, causing sleep disturbance, symptoms of anxiety and
depression and feelings of isolation in children.
“The approval of Dupixent for children in
Europe marks another significant milestone for atopic dermatitis
patients and their families, broadening the availability of a
first-in-class medicine that offers a proven safe and effective
treatment for this debilitating skin disease,” said John Reed,
M.D., Ph.D., Global Head of Research and Development at Sanofi.
“Dupixent’s ability to provide significantly clearer skin, and
clinically meaningful reduction of persistent itch, addresses
important unmet needs for these children. In addition to atopic
dermatitis, we continue to investigate the potential of Dupixent in
younger age groups and across a variety of 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, 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 chronic rhinosinusitis with nasal
polyposis (CRSwNP).
“This approval for Dupixent in the EU represents
a major advancement for children with severe atopic dermatitis and
their families, who spend countless days and nights tending to
their child’s disease with few treatment options to help alleviate
the debilitating symptoms,” said George D. Yancopoulos, M.D.,
Ph.D., President and Chief Scientific Officer at Regeneron.
“Dupixent is a novel therapy that addresses a root cause of atopic
dermatitis by specifically targeting the underlying type 2
inflammation of the disease. Dupixent has already been used by
hundreds of thousands of patients around the world, including those
with atopic dermatitis as well as other type 2 inflammatory
diseases such as asthma and adults with chronic rhinosinusitis with
nasal polyps. We are pleased to bring this paradigm-changing
medicine to even younger patients in the EU who need new options
beyond steroids or immunosuppressants.”
In children aged 6-11 years weighing 15 to
<60 kg, Dupixent 300 mg is administered as an injection under
the skin (subcutaneous injection) every four weeks following the
initial loading dose given as two injections 14 days apart. For
those weighing >60 kg, Dupixent 300 mg is administered every two
weeks following the initial loading dose given the same day. The
dose may be increased to 200 mg every two weeks in patients
weighing 15 to <60 kg based on physician’s assessment.
Pivotal trial data
The EC decision is based primarily on data that
includes pivotal Phase 3 efficacy and safety results of Dupixent
combined with topical corticosteroids (TCS) compared to TCS alone
(placebo) in children 6-11 years with severe atopic dermatitis. At
16 weeks, patients in treatment groups of Dupixent 300 mg every
four weeks (N=122) or 200 mg every two weeks (N=59) with TCS
experienced:
- Improved disease extent and severity: 82% and
80% average improvement from baseline with Dupixent every four and
two weeks, respectively, compared to 49% and 48% for placebo. In
addition, 70% and 75% of Dupixent patients achieved at least a 75%
improvement in the four-week and two-week treatment groups,
respectively, compared to 17% and 26% for placebo.
- Skin clearance: 33% and 39% of patients
achieved clear or almost clear skin with Dupixent every four and
two weeks respectively, compared to 11% and 10% for placebo.
- Reduced itch: 51% and 61% of patients achieved
clinically significant reduction with Dupixent every four and two
weeks, respectively, compared to 12% and 13% for placebo. A
significantly greater proportion of Dupixent patients achieved
improvement in itch as early as four weeks.
- Improved health-related quality of life
(HR-QoL): 77% and 81% of patients experienced clinically
meaningful improvement in patient-reported HR-QoLwith Dupixent
every four and two weeks, respectively, compared to 39% and 36% for
placebo. Dupixent patients also experienced improvements in
additional HR-QoL measures assessing disease severity and
patient-reported measures such as itch and sleep.
The safety profile of Dupixent in children 6-11
years of age followed through week 52, based on an open-label
extension trial, was similar to the safety profile observed at week
16 and consistent with the safety profile seen in adults and
adolescents with atopic dermatitis. Overall rates of adverse events
(AEs) were 65% and 61% for Dupixent every four and two weeks
respectively, and 73% and 75% for placebo. AEs that were more
commonly observed with Dupixent included upper respiratory tract
infections (11% and 9% for Dupixent every four and two weeks, 10%
and 12% for placebo), injection site reactions (10% and 14% for
Dupixent every four and two weeks, 6% and 5% for placebo),
nasopharyngitis (13% and 3% for Dupixent every four and two weeks,
7% and 10% for placebo), conjunctivitis (7% and 9% for Dupixent
every four and two weeks, 4% and 5% for placebo), and fever (3% for
both Dupixent groups, 2% and 0% for placebo). Additional
prespecified AEs included skin infections (6% and 9% for Dupixent
every four and two weeks, 13% for both placebo groups), and herpes
viral infections (2% for both Dupixent groups, 5% for both placebo
groups).
About the pediatric trial
The co-primary endpoints in the pediatric trial
were skin clearance, as measured by a score of 0 or 1 on the
Investigator's Global Assessment (IGA), and disease extent and
severity, as measured by Eczema Area and Severity Index score
(EASI-75).
Secondary endpoints included the average change
in EASI score from baseline, and itch as measured by at least a
4-point reduction in itch intensity on a 0 to 10-point scale
(weekly average of daily Peak Pruritus Numerical Rating Scale).
Additionally, HR-QoL was measured by the proportion of patients who
achieved at least six points on the patient-reported Children’s
Dermatology Life Quality Index (CDLQI), as well as additional
measures from Patient Oriented Eczema Measure (POEM) and SCORing
Atopic Dermatitis (SCORAD).
About Dupixent
Dupixent is approved for specific patients with
atopic dermatitis, asthma and/or in adults with CRSwNP in a number
of countries around the world, including the European Union, U.S.
and Japan. Dupixent is currently approved in more than 60
countries, and more than 200,000 patients have been treated
globally.
Dupixent is intended for use under the guidance
of a healthcare professional and can be given in a clinic or at
home by self-administration after training by a healthcare
professional. In children younger than 12 years of age, Dupixent
should be administered by a caregiver. No initial lab testing or
ongoing lab monitoring is required with Dupixent treatment in any
approved indication or age group.
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 diseases driven by type 2 inflammation and other
allergic pathways, including pediatric atopic dermatitis (6 months
to 5 years of age, Phase 3), pediatric asthma (6 to 11 years of
age, Phase 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 of
dupilumab in these conditions have not been evaluated by any
regulatory authority. Dupilumab is being jointly developed by
Sanofi and Regeneron under a global collaboration agreement.
About Regeneron
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 eight
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 |
Sanofi Media Relations
Contact Sally Bain Tel.: +1 (781) 264-1091
Sally.Bain@sanofi.com
Regeneron Media Relations Contact Hannah KwaghTel:
+1 (914) 847-6314Hannah.Kwagh@regeneron.com |
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