TARRYTOWN, N.Y., April 23, 2021 /PRNewswire/ --
Nearly 30 data presentations at AAD and ESPD highlight the
impact of Dupixent on disease measures including rapid itch relief
and sustained improvement in disease severity, as well as quality
of life in clinical and real-world settings
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced
that new analyses of Dupixent® (dupilumab) in patients
as young as 6 years with moderate-to-severe atopic dermatitis will
be presented at the American Academy of Dermatology Annual Meeting
(AAD VMX 2021) from April 23-25, and
at the 20th European Society for Pediatric Dermatology
Annual Meeting (ESPD 2021) from May
12-14.
"Atopic dermatitis is a debilitating disease that
spares no age group and is associated with persistent itch and
painful lesions that can impair quality of life, affecting the
entire family," said Bola Akinlade, M.D., Vice President, Clinical
Sciences, Immunology and Inflammation, at Regeneron. "The depth and
breadth of our data being presented at AAD and ESPD show the rapid
and long-term effect of Dupixent in adults, adolescents and
children, addressing the key disease measures that are top of mind
for patients and treating physicians. Further, our data
continue to support the established safety profile of
Dupixent, which can be one of the most important factors impacting
treatment decisions for this chronic
disease."
Regeneron and Sanofi will present results from clinical and
real-world settings including long-term data from Dupixent
open-label extension (OLE) trials, up to three years in adults and
up to one year in adolescents (aged 12 to 17 years) and children
(aged 6 to 11 years) with moderate-to-severe atopic dermatitis. In
the adult analysis, a lower rate of overall infections was observed
in the Dupixent long-term treatment group compared to the placebo
group in the one-year CHRONOS trial. Additional long-term analyses
on laboratory blood measures further reinforce that patients 6
years and older who take Dupixent do not require ongoing laboratory
blood monitoring. Across age groups, researchers evaluated the
response rates across a broad patient population, as well as the
impact of Dupixent on disease extent and severity, quality of life
and itch.
Dupixent is a fully human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
pathways and is not an immunosuppressant. It was invented using
Regeneron's proprietary VelocImmune® technology.
IL-4 and IL-13 are key and central drivers of the type 2
inflammation that plays a major role in atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis (CRSwNP) and
eosinophilic esophagitis.
Abstracts to be presented at AAD VMX 2021
Abstracts
presenting research on Dupixent and evaluation of efficacy, safety
and impact on health-related quality of life include:
Pediatric efficacy and quality of life data
- Abstract #27350: Dupilumab Improves Eczema Area and
Severity Index Regional Scores Across All Anatomical Regions in
Children Aged 6–11 Years with Severe Atopic Dermatitis (AD),
Amy S. Paller
- Abstract #27375: Dupilumab Provides Early and Sustained
Improvement of Sleep Disturbance in Children ≥ 6 Years With Severe
Atopic Dermatitis (AD) and Adolescents With Moderate-to-Severe AD,
Amy S. Paller
- Abstract #27389: Rapid and Sustained Improvement in Itch
in Children Aged 6–11 Years With Severe Atopic Dermatitis (AD)
Treated With Dupilumab: Analysis From the LIBERTY AD PEDS Phase 3
Trial, Amy S. Paller
- Abstract #27394: Dupilumab Provides Clinically
Meaningful Improvement in Atopic Dermatitis (AD) Signs, Symptoms,
and Quality of Life in Children With Severe AD: Results From the
LIBERTY AD PEDS Phase 3 Clinical Trial, Amy
S. Paller
- Abstract #27406: Dupilumab Improves Signs and Symptoms
of Severe Atopic Dermatitis in Children Aged 6–11 Years With and
Without Comorbid Asthma, Mark
Boguniewicz
- Abstract #27431: Dupilumab Treatment Improves
Health-Related Quality of Life in Children Aged ≥6 to <12 Years
With Severe Atopic Dermatitis, Alan
Irvine
Adult efficacy data
- Abstract #26839: Dupilumab With Topical Corticosteroids
Results in Rapid and Sustained Improvement in Adults with
Moderate-to-Severe Atopic Dermatitis Across All Anatomic Regions
Over 52 Weeks, Andrew Blauvelt
- Abstract #27571: Dupilumab Provides Clinically
Meaningful Responses in Adults With Moderate-To-Severe Atopic
Dermatitis (AD): Results From LIBERTY AD CHRONOS Study,
Jonathan I. Silverberg
Long-term data
- Abstract #26313: Efficacy and Safety of Dupilumab for up
to 1 Year in a Phase 3 Open-Label Extension (OLE) Trial (LIBERTY AD
PED-OLE) in Adolescents With Uncontrolled, Moderate-To-Severe
Atopic Dermatitis (AD), Andrew
Blauvelt
- Abstract #26875: 52-Week Laboratory Safety Findings From
an Open-Label Extension (OLE) Study of Dupilumab in Adolescent
Patients With Atopic Dermatitis (LIBERTY AD PED-OLE), Michael J. Cork
- Abstract #26880: Long-Term Efficacy and Safety Data for
Dupilumab in a Phase 3, Open-Label Extension Trial (LIBERTY AD
PED-OLE) in Patients Aged ≥6 to <12 Years With Uncontrolled,
Moderate-to-Severe Atopic Dermatitis (AD), Michael J. Cork
- Abstract #27419: Laboratory Safety of Long-Term
Dupilumab Treatment in Adults With Moderate-to-Severe Atopic
Dermatitis: Open-Label Extension (OLE) Study, Andrew Blauvelt
- Abstract #27424: Infections in Adults with
Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab:
Long-Term Data from an Open-Label Extension (OLE) Study,
Andrew Blauvelt
Real-world data
- Abstract #27434: Early Trends of Disease Improvement in
Adult Patients With Atopic Dermatitis Treated With Dupilumab:
Real-World Data From the PROSE Registry, Jerry Bagel
Abstracts presenting research on the burden, impact and care of
atopic dermatitis include:
- Abstract #27430: Worldwide Survey Shows That Atopic
Dermatitis Is Associated with a High Disease Burden in Children,
Stephan Weidinger
- Abstract #27473: Worldwide Survey Shows That Atopic
Dermatitis in Children is Associated with a Negative Impact on
Their Families, Sebastien Barbarot
- Abstract #28081: Strategies to Improve Quality of Atopic
Dermatitis Care in the North
America: Results from the Atopic Dermatitis Quality of Care
(ADQoC) Initiative, Peter Lio
Abstracts to be presented at ESPD 2021
Abstracts
related to the research for Dupixent and evaluation of efficacy,
safety and impact on health-related quality of life include:
Efficacy data
- ESPD21-0326: Dupilumab Provides Clinically Meaningful
Improvement in Atopic Dermatitis (AD) Signs, Symptoms, and Quality
of Life in Children With Severe AD, Stephan
Weidinger
- ESPD21-0330: Dupilumab Improves EASI Regional Scores
Across All Anatomical Regions in Children Aged ≥6–<12 Years With
Severe Atopic Dermatitis, Michael J.
Cork
- ESPD21-0331: Rapid Itch Improvement in Children With
Severe Atopic Dermatitis Treated With Dupilumab: A Phase 3 Subset
Analysis, Gil Yosipovitch
- ESPD21-0332: Dupilumab Significantly Improves Signs and
Symptoms of Atopic Dermatitis Assessed by SCORAD in Children Aged
≥6 to <12 Years, Sebastien Barbarot
- ESPD21-0334: Dupilumab Treatment Improves Health-Related
Quality of Life in Children Aged ≥6 to <12 Years With Severe
Atopic Dermatitis, Alan Irvine
- ESPD21-0340: Dupilumab Improved Itch in Children Aged
6–11 Years With Severe Atopic Dermatitis: Analysis from the LIBERTY
AD PEDS Trial, Amy S. Paller
- ESPD21-0341: Dupilumab Treatment Improves Sleep in
Children Aged ≥6 to <12 Years With Severe Atopic Dermatitis,
Amy S. Paller
Long-term data
- ESPD21-0335: Long-Term Efficacy and Safety of Dupilumab
in a Phase 3, Open-Label Extension Trial in Children With
Uncontrolled, Moderate-to-Severe Atopic Dermatitis, Michael J. Cork
Safety data
- ESPD21-0200: Increased Incidence of Conjunctivitis With
Dupilumab Treatment in Adolescents Appears to be Specific to Atopic
Dermatitis, Marjolein De
Bruin-Weller
- ESPD21-0308: Laboratory Safety of Dupilumab in Children
Aged ≥6–<12 Years With Severe Atopic Dermatitis: Results From a
Phase 3 Trial, Andreas
Wollenberg
Results from a qualitative survey on the impact of atopic
dermatitis
- ESPD21-0322: AD-GAP: A Global, Cross-sectional,
Qualitative Survey of Children/Adolescents Aged 6−17 Years With
Moderate-to-Severe Atopic Dermatitis, Their Carers, and Physicians,
Stephan Weidinger
About Dupixent
Dupixent is approved in the U.S. to
treat patients aged 6 years and older with moderate-to-severe
atopic dermatitis that is not well controlled with prescription
therapies used on the skin (topical), or who cannot use topical
therapies; for use with other asthma medicines for the maintenance
treatment of moderate-to-severe eosinophilic or oral steroid
dependent asthma in patients aged 12 years and older whose asthma
is not controlled with their current asthma medicines; and for use
with other medicines for the maintenance treatment of CRSwNP in
adults whose disease is not controlled.
Outside of the U.S., Dupixent is approved for specific patients
with moderate-to-severe atopic dermatitis and certain patients with
asthma in a number of other countries around the world, including
those in the EU and Japan.
Dupixent is also approved in the EU and Japan to treat certain adults with severe
CRSwNP. Across all approved indications globally, more than 260,000
patients have been treated with Dupixent.
About Regeneron's VelocImmune®
Technology
Regeneron's VelocImmune technology
utilizes a proprietary genetically engineered mouse platform
endowed with a genetically humanized immune system to produce
optimized fully human antibodies. When Regeneron's co-Founder,
President and Chief Scientific Officer George D. Yancopoulos was a graduate student
with his mentor Frederick W. Alt in
1985, they were the first to envision making such a genetically
humanized mouse, and Regeneron has spent decades inventing and
developing VelocImmune and related
VelociSuite® technologies. Dr. Yancopoulos and
his team have used VelocImmune technology to create
approximately a quarter of all original, FDA-approved fully human
monoclonal antibodies currently available. This includes
REGEN-COV™ (casirivimab with imdevimab), Dupixent®
(dupilumab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza™ (evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab
and odesivimab-ebgn).
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 studying dupilumab in a broad range of diseases driven
by type 2 inflammation or other allergic processes, including
pediatric asthma (6 to 11 years of age, Phase 3), chronic
obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid
(Phase 3), prurigo nodularis (Phase 3), chronic spontaneous
urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3),
chronic rhinosinusitis without nasal polyposis (Phase 3), allergic
fungal rhinosinusitis (Phase 3) and food allergies (Phase 2). These
potential uses are under clinical investigation, and the safety and
efficacy of dupilumab in these conditions have not been fully
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 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 over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to nine
FDA-approved treatments and numerous product candidates in
development, almost 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.
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
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uncertainties include, among others, the impact of SARS-CoV-2 (the
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
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its collaborators (collectively, "Regeneron's Product Candidates")
and research and clinical programs now underway or planned,
including without limitation Dupixent® (dupilumab);
uncertainty of market acceptance and commercial success of
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Candidates and the impact of studies (whether conducted
by Regeneron or others and whether mandated or voluntary),
including the studies discussed in this press release, on the
commercial success of Regeneron's Products (such as
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possible regulatory approval and commercial launch of Regeneron's
Product Candidates and new indications for Regeneron's Products,
such dupilumab for the treatment of pediatric atopic
dermatitis, pediatric asthma, chronic obstructive pulmonary
disease, eosinophilic esophagitis, bullous pemphigoid, prurigo
nodularis, chronic spontaneous urticaria, chronic inducible
urticaria-cold, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, food and environmental allergies,
and other potential indications; safety issues resulting
from the administration of Regeneron's Products (such as
Dupixent) and Regeneron's Product
Candidates in patients, including serious complications
or side effects in connection with the use of
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obligations and oversight impacting Regeneron's Products, research
and clinical programs, and business, including those relating to
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payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and
government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron's Products and Regeneron's 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 studies and/or lead to advancement of product
candidates to 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
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unanticipated expenses; the costs of developing, producing, and
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financial projections or guidance and changes to the assumptions
underlying those projections or guidance; the potential for any
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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, Praluent®
(alirocumab), and REGEN-COVTM (casirivimab with
imdevimab)), 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
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Commission, including its Form 10-K for the year ended December 31, 2020. Any forward-looking
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