TARRYTOWN, N.Y. and
PARIS, Nov.
30, 2020 /PRNewswire/ --
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
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that 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.
"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."
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins, that was invented using Regeneron's proprietary
VelocImmune® technology, 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).
"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."
In children aged 6 to 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.
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 to 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% average improvement from baseline with Dupixent every four
weeks compared to 49% for placebo.
- 80% average improvement from baseline with Dupixent every two
weeks compared to 48% for placebo.
- 70% of patients in the every four week treatment group achieved
at least a 75% improvement compared to 17% for placebo.
- 75% of patients in the every two week treatment group achieved
at least a 75% improvement compared to 26% for placebo.
-- Skin clearance:
- 33% of patients achieved clear or almost clear skin with
Dupixent every four weeks compared to 11% for placebo.
- 39% of patients achieved clear or almost clear skin with
Dupixent every two weeks compared to 10% for placebo.
-- Reduced itch:
- 51% of patients achieved clinically significant reduction of
itch with Dupixent every four weeks compared to 12% for
placebo.
- 61% of patients achieved clinically significant reduction of
itch with Dupixent every two weeks compared to 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% of patients experienced clinically meaningful improvement
in patient-reported HR-QoL with Dupixent every four weeks compared
to 39% for placebo.
- 81% of patients experienced clinically meaningful improvement
in patient-reported HR-QoL with Dupixent every two weeks compared
to 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 to 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 was invented using Regeneron's
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been used to
create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Zaire ebolavirus infection, which is
approved by the FDA, and to create a potentially preventative and
therapeutic investigational medicine for COVID-19 that was recently
granted Emergency Use Authorization (EUA).
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, Regeneron and
Sanofi 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 Regeneron and Sanofi under
a global collaboration agreement.
U.S. Indications
DUPIXENT is
a prescription medicine used:
- to treat people aged 6 years 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 6 years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent 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 for the maintenance treatment of chronic
rhinosinusitis with nasal polyposis (CRSwNP) 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
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.
- There is a pregnancy exposure registry for women who take
DUPIXENT during pregnancy to collect information about the health
of you and your baby. Your healthcare provider can enroll you or
you may enroll yourself. To get more information about the registry
call 1–877-311-8972 or go to
https://mothertobaby.org/ongoing-study/dupixent/.
-- 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.
Especially tell your healthcare provider if you are taking oral,
topical, or inhaled corticosteroid medicines; have asthma and use
an asthma medicine; or have atopic dermatitis or CRSwNP, and also
have asthma. Do not change or stop your corticosteroid
medicine or other asthma medicine without talking to your
healthcare provider. This may cause other symptoms that were
controlled by the corticosteroid medicine or other asthma medicine
to come back.
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 by
indication are as follows:
- 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. Your
healthcare provider will tell you how much DUPIXENT to inject and
how often to inject it. 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. In children
younger than 12 years of age, DUPIXENT should be given by a
caregiver.
Please see 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 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
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 as
"anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying
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virus that has caused the COVID-19 pandemic) on Regeneron's
business and its employees, collaborators, and suppliers and other
third parties on which Regeneron relies, Regeneron's and its
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Regeneron and/or its collaborators (collectively, "Regeneron's
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possible success and therapeutic applications of Regeneron's
Products and Regeneron's product candidates and research and
clinical programs now underway or planned, including without
limitation Dupixent® (dupilumab); uncertainty of market
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Regeneron or others and whether mandated or voluntary) on the
commercial success of Regeneron's Products (such as Dupixent) and
product candidates; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's product
candidates and new indications for Regeneron's Products, such as
dupilumab for the treatment of pediatric atopic dermatitis,
pediatric asthma, eosinophilic esophagitis, chronic obstructive
pulmonary disease, bullous pemphigoid, prurigo nodularis, chronic
spontaneous urticaria, food and environmental allergies, and other
potential indications; safety issues resulting from
the administration of Regeneron's Products (such as Dupixent) and
product candidates in patients, including serious complications or
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and administrative governmental authorities which may delay or
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candidates that may be superior to, or more cost effective than,
Regeneron's Products and product candidates; the extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may be replicated in other
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clinical trials, therapeutic applications, or regulatory approval;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
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Regeneron's Products and product candidates; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its financial projections
or guidance and changes to the assumptions underlying those
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agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), to
be cancelled or terminated; 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)), other litigation and other proceedings and
government investigations relating to the Company and/or its
operations, the ultimate outcome of any such proceedings and
investigations, and the impact any of the foregoing may have on
Regeneron's business, prospects, operating results, and financial
condition. A more complete description of these and other material
risks can be found in Regeneron's filings with the U.S. Securities
and Exchange Commission, including its Form 10-K for the year ended
December 31, 2019 and its Form 10-Q
for the quarterly period ended September
30, 2020. Any forward-looking statements are made
based on management's current beliefs and judgment, and the reader
is cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
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without limitation any financial projection or guidance, whether as
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Regeneron
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Mark.Hudson@regeneron.com
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Sanofi
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Sanofi Investor Relations – Contacts
Paris Eva
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Naughton
Sanofi Investor
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45 45 ir@sanofi.com https://www.sanofi.com/en/investors/contact
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