TARRYTOWN, N.Y. and
PARIS, Aug.
30, 2021 /PRNewswire/ --
Dupixent rapidly improved symptoms after first dose,
improving itch in one week and skin clearance in two weeks
More than seven times as many patients treated with Dupixent
plus topical corticosteroids (TCS) achieved clear or almost clear
skin compared to TCS alone at week 16
Dupixent plus TCS reduced overall disease severity by 70% and
itch by 49%
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced positive pivotal Phase 3 results from a trial evaluating
Dupixent® (dupilumab) to treat moderate-to-severe atopic
dermatitis in children aged 6 months to 5 years. The trial met its
primary and all secondary endpoints, showing that Dupixent
added to standard-of-care topical corticosteroids (TCS)
significantly reduced overall disease severity and improved skin
clearance, itch and health-related quality of life measures at 16
weeks compared to TCS alone (placebo). Dupixent is the first
biologic medicine to show positive results in this young population
and remains the only approved biologic medicine in patients 6 years
and older with uncontrolled moderate-to-severe atopic
dermatitis.
The data reinforce the well-established efficacy and safety
profile of Dupixent in other age groups, including a lower observed
rate of skin infections in the Dupixent group compared to placebo.
During the 16-week treatment period, Dupixent patients were 50%
less likely to experience a skin infection (12% Dupixent, 24%
placebo), and the total number of infections was nearly 70% lower
(11 Dupixent, 34 placebo). These results add to the extensive
LIBERTY AD clinical program – the largest Phase 3 clinical trial
program in atopic dermatitis involving approximately 3,500
children, adolescents and adults to date.
"Moderate-to-severe atopic dermatitis in infants and young
children is incredibly distressing for patients and their
caregivers, who manage painful and persistent itch, intensive daily
skincare routines such as chlorine baths and wet wraps, as well as
sleepless nights for children and their families," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "In fact, when
starting this trial, the disease covered more than half of
children's bodies and nearly a third of patients had previously
resorted to using immunosuppressive medicines. These data show that
Dupixent dramatically reduced the impact of atopic dermatitis on
the lives of these young children and their families, with rapidly
cleared skin, improved itch and improved observed patient
outcomes, including sleep and skin pain. Importantly, Dupixent
provided its benefits without acting as a broad immunosuppressant.
In fact, Dupixent-treated patients experienced nearly 70% fewer
skin infections compared to placebo patients."
Atopic dermatitis is a chronic type 2 inflammatory skin disease,
with the age of onset younger than 5 years in 85 to 90% of
patients. The debilitating symptoms that infants and young children
with moderate-to-severe atopic dermatitis experience often continue
through adulthood and include intense, persistent itch and skin
lesions that can cover much of the body, resulting in skin dryness,
cracking, redness or darkening, and crusting and oozing, along with
increased risk of skin infections. Moderate-to-severe atopic
dermatitis significantly impacts the life of a young child,
their parents and caregivers, including their mood, sleep patterns,
and quality of life. In addition, the underlying type 2
inflammation involved in atopic dermatitis can contribute to the
development of other atopic diseases, like asthma and certain
allergies, that may also appear throughout a person's life.
"When a child is diagnosed with moderate-to-severe atopic
dermatitis in the first few months of life, many aspects of their
childhood can be significantly impacted. Parents and caregivers are
challenged to find safe and effective treatment options," said
John Reed, M.D., Ph.D., Global Head
of Research and Development at Sanofi. "Currently, the standard of
care for this patient population is topical steroids and other
immunosuppressive medicines may be used which can damage delicate
skin and, if used long-term, potentially impact growth. Knowing
that safety is of the utmost importance for physicians and parents
when considering treatment options for children and infants, we are
encouraged by the results of this trial showing Dupixent addressed
the signs and symptoms of atopic dermatitis without broadly
suppressing the immune system, demonstrating the potential it could
have for these very young patients."
Patients received Dupixent every four weeks (200 mg or
300 mg, based on body weight) plus TCS or placebo. The primary
endpoints assessed the proportion of patients achieving an
Investigator's Global Assessment (IGA) score of 0 (clear) or 1
(almost clear) and 75% improvement in Eczema Area and Severity
Index (EASI-75). The pre-specified primary analysis showed that at
16 weeks, among patients treated with Dupixent:
- 28% achieved clear or almost-clear skin compared to 4% with
placebo (p<0.0001), the primary endpoint.
- 53% achieved 75% or greater overall disease improvement from
baseline compared to 11% with placebo (p<0.0001), the co-primary
endpoint outside of the U.S.
- 70% average improvement from baseline in overall disease
severity (EASI) compared to 20% improvement with placebo
(p<0.0001).
- 49% average improvement from baseline in itch compared to 2%
improvement with placebo (p<0.0001).
- Significantly improved measures of observed patient outcomes
(including sleep, skin pain and health-related quality of life), as
well as caregiver-reported health-related quality of life.
The trial demonstrated similar safety results to the known
safety profile of Dupixent in atopic dermatitis. For the 16-week
treatment period, overall rates of adverse events (AEs) were
64% for Dupixent and 74% for placebo. Most common AEs and AEs of
special interest included nasopharyngitis (8% Dupixent, 9%
placebo), upper respiratory tract infection (6% Dupixent, 8%
placebo), conjunctivitis (5% Dupixent, 0% placebo), herpes viral
infections (6% Dupixent, 5% placebo) and injection site reactions
(2% Dupixent, 3% placebo).
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
and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Detailed results from this trial will be presented at a future
medical meeting, and data will be submitted to regulatory
authorities. In 2016, the FDA granted Breakthrough Therapy
designation for Dupixent for the treatment of severe atopic
dermatitis (in children aged 6 months to 11 years of age). The
efficacy and safety of Dupixent in children below the age of 6
years have not been fully evaluated by any regulatory
authority.
About the Dupixent Trial
LIBERTY AD PRESCHOOL is a
two-part Phase 2/3 trial. The Phase 3 randomized, double-blind,
placebo-controlled trial (Part B) evaluated the efficacy and safety
of Dupixent added to standard-of-care low-potency TCS compared to
low-potency TCS alone (placebo) in 162 children aged 6 months to 5
years with uncontrolled moderate-to-severe atopic dermatitis.
The primary endpoints assessed the proportion of patients
achieving an Investigator's Global Assessment (IGA) score of 0
(clear) or 1 (almost clear) and 75% improvement in Eczema Area and
Severity Index (EASI-75) at 16 weeks. EASI measures extent and
severity of the disease. Itch was assessed using a 0 to 10
Numerical Rating Scale. Patients treated with Dupixent received
either 200 mg (for children weighing ≥5 to <15 kg) or 300
mg (for children weighing ≥15 to <30 kg) every four
weeks.
In total, there were 162 patients in the trial, the average age
was 3.8 years and 61% were male. Approximately 12% of patients were
Latino/Hispanic and 19% were Black/African American. On average,
patients entered the trial with atopic dermatitis covering 58% of
their body, and 29% had previously used systemic
immunosuppressants. Furthermore, 81% of these patients had at least
one concurrent type 2 inflammatory and/or allergic condition such
as allergic rhinitis and asthma.
Part B of the Phase 3 trial was informed by Part A, which was an
open-label, single-ascending-dose, sequential cohort Phase 2 trial
designed to assess the pharmacokinetics and safety of Dupixent in
children aged 6 months to 5 years with uncontrolled severe atopic
dermatitis.
Children who completed Part A or Part B of the trial were
eligible to enroll in an open-label extension trial to assess the
safety and efficacy of long-term treatment with Dupixent in this
age group.
About Dupixent
Dupixent is currently approved in the
U.S., Europe, Japan and other countries around the world for
use in specific patients with moderate-to-severe atopic dermatitis,
as well as certain patients with asthma or CRSwNP in different age
populations. Dupixent is also approved in one or more of these
indications in more than 60 countries around the world and more
than 300,000 patients have been treated globally.
Dupilumab Development Program
To date, dupilumab has
been studied across 60 clinical trials involving more than 10,000
patients with various chronic diseases driven in part by type 2
inflammation.
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), allergic bronchopulmonary
aspergillosis (Phase 3) and peanut allergy (Phase 2). These
potential uses of dupilumab are currently under clinical
investigation, and the safety and efficacy 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.
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 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 or authorized
fully human monoclonal antibodies currently available. This
includes Dupixent, REGEN-COV™ (casirivimab and imdevimab),
Libtayo® (cemiplimab-rwlc), Praluent®
(alirocumab), Kevzara® (sarilumab), Evkeeza®
(evinacumab-dgnb) and Inmazeb™ (atoltivimab, maftivimab, and
odesivimab-ebgn).
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, hematologic
conditions, 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.
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
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all forward-looking statements contain these identifying words.
These statements concern, and these risks and 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 collaborators' ability
to continue to conduct research and clinical programs, Regeneron's
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candidates being developed by Regeneron and/or its collaborators
(collectively, "Regeneron's Product Candidates") and research and
clinical programs now underway or planned, including without
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moderate-to-severe atopic dermatitis in children aged 6 months to 5
years; 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
Dupixent for the treatment of pediatric atopic dermatitis,
pediatric asthma, chronic obstructive pulmonary disease with
evidence of type 2 inflammation, eosinophilic esophagitis, bullous
pemphigoid, prurigo nodularis, chronic spontaneous urticaria,
chronic inducible urticaria-cold, chronic rhinosinusitis without
nasal polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis, peanut allergy, and other potential
indications; uncertainty of the utilization, market
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any of the foregoing or any potential regulatory approval of
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ability of Regeneron's collaborators, suppliers, or other third
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related to Regeneron's Products and Regeneron's Product Candidates;
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administration of Regeneron's Products (such as Dupixent) and
Regeneron's Product Candidates in patients, including serious
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trials; determinations by regulatory and administrative
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ability to continue to develop or commercialize Regeneron's
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business, including those relating to patient privacy; the
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benefit management companies, and government programs such as
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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
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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
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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 and 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
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and Exchange Commission, including its Form 10-K for the year ended
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for the quarterly period ended June 30,
2021. 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
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Forward-looking statements are generally identified by the words
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Regeneron
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SOURCE Regeneron Pharmaceuticals, Inc.