TARRYTOWN, N.Y. and
PARIS, Dec.
13, 2021 /PRNewswire/ --
Dupixent significantly improved skin clearance and reduced
overall disease severity and itch in pivotal trial that met all
primary and secondary endpoints
Global regulatory filings planned in the coming months,
starting with the U.S. by the end of 2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced detailed positive Phase 3 results that showed adding
Dupixent® (dupilumab) to standard-of-care topical
corticosteroids (TCS) significantly improved skin clearance and
reduced overall disease severity and itch in infants and children
aged 6 months to 5 years with uncontrolled moderate-to-severe
atopic dermatitis. These data will be presented today in a
late-breaking session at the 2021 Revolutionizing Atopic Dermatitis
Conference (RAD 2021).
"One of most challenging aspects of my job as a physician is
having limited treatment options to help babies and young children
suffering from moderate-to-severe atopic dermatitis, which can
disrupt their ability to fully thrive in these early years of
life," said Amy S. Paller, M.D,
Walter J. Hamlin Professor and Chair of Dermatology and Professor
of Pediatrics at Northwestern
University Feinberg School of Medicine, and principal
investigator of the trial. "These results show dupilumab can
significantly improve the signs and overall severity of atopic
dermatitis in children as young as 6 months. Safety is of paramount
importance when treating children at such a young age. We are
encouraged that these data show a safety profile consistent with
what has been seen in other age groups. We will continue to follow
these patients for up to 5 years in an open-label trial."
Eighty-five to 90% of patients with atopic dermatitis develop
symptoms before the age of 5, which can often continue through
adulthood. Symptoms include intense, persistent itch and skin
lesions that cover much of the body (58% on average for the
patients in this trial at baseline), resulting in skin dryness,
cracking, redness or darkening, and crusting and oozing, along with
increased risk of skin infections. Moderate-to-severe atopic
dermatitis may also significantly impact the quality of life of a
young child, their parents and caregivers. In addition, the
underlying type 2 inflammation involved in atopic dermatitis can
contribute to the development of other diseases, like asthma and
certain allergies, that may also appear throughout a person's
life.
Topline results from the randomized, placebo-controlled pivotal
trial, which met all primary and secondary endpoints, were
announced in August 2021. Data
presented at RAD 2021 showed that at 16 weeks, patients who added
Dupixent to low-potency TCS experienced the following, compared to
low-potency TCS alone (placebo):
- 28% achieved clear or almost-clear skin compared to 4% with
placebo (p<0.0001), the primary endpoint.
- 70% average improvement from baseline in disease severity
compared to 20% improvement with placebo (p<0.0001), a key
secondary endpoint.
- 53% achieved 75% or greater improvement in overall disease
severity from baseline compared to 11% with placebo (p<0.0001),
the co-primary endpoint outside of the U.S.
- 49% average improvement from baseline in itch compared to 2%
improvement with placebo (p<0.0001).
The safety profile observed in the randomized,
placebo-controlled trial was consistent with the well-established
safety profile of Dupixent in adults, adolescents and children 6
years and older with moderate-to-severe atopic dermatitis. 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) and herpes viral infections (6% Dupixent, 5%
placebo).
These results will form the basis of global regulatory
submissions for this age group, beginning with the U.S. in 2021 and
European Union in the first half of 2022.
Additionally, long-term data from the Phase 3 trial in patients
aged 6 to 11 years with moderate-to-severe atopic dermatitis are
also being presented in a late-breaking session. Efficacy and
safety results at one year were consistent with the known profile
of Dupixent in atopic dermatitis.
The data from these trials add to the extensive LIBERTY AD
clinical program – the largest Phase 3 clinical trial program in
atopic dermatitis, involving approximately 3,500 infants, children,
adolescents and adults to date.
Dupixent is the first biologic medicine to demonstrate positive
results in this young patient population. 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 part of the 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 week 16. EASI measures extent and
severity of the disease. Itch was assessed using a
caregiver-reported 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 (83 Dupixent, 79
placebo), the average age was 3.8 years and 61% were male.
Approximately 12% of patients were Latino/Hispanic and 19% were
Black/African American. At the start of the trial, 77% of patients
had severe disease and 29% had previously used systemic
immunosuppressants for their atopic dermatitis, and on average,
patients had atopic dermatitis covering 58% of their body.
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 for an additional five years.
About Dupixent
Dupixent, which was invented using
Regeneron's proprietary VelocImmune® technology,
is a fully human monoclonal antibody that inhibits the signaling of
the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
Dupixent is not an immunosuppressant and does not require lab
monitoring. 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).
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.
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).
Dupilumab Development Program
Dupilumab is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. 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.
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 atopic dermatitis (6 months to 5 years of age, Phase 3),
chronic obstructive pulmonary disease with evidence of type 2
inflammation (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.
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 6 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 6 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.
-
- A pregnancy registry for women who take DUPIXENT during
pregnancy collects information about the health of you and your
baby. To enroll or get more information 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), high count of a certain white blood cell
(eosinophilia), and parasitic (helminth) infections.
- 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
intended to identify such forward-looking statements, although not
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
ability to manage its supply chain, net product sales of products
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collaborators or licensees (collectively, "Regeneron's Products"),
and the global economy; the nature, timing, and possible success
and therapeutic applications of Regeneron's Products and product
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licensees (collectively, "Regeneron's Product Candidates") and
research and clinical programs now underway or planned, including
without limitation Dupixent® (dupilumab) for the
treatment of 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, 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 acceptance, and
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Candidates and the impact of studies (whether conducted by
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the study discussed in this press release, on any of the foregoing
or any potential regulatory approval of Regeneron's Products (such
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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
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
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limitation Dupixent; ongoing regulatory obligations and oversight
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business, including those relating to patient privacy; the
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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
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research and development programs conducted by Regeneron and/or its
collaborators or licensees may be replicated in other studies
and/or lead to advancement of product candidates to clinical
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unanticipated expenses; the costs of developing, producing, and
selling products; the ability of Regeneron to meet any of its
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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), as
well as its REGEN-COV® (casirivimab and imdevimab)
supply agreement with the U.S. government, 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-COV), 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
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Commission, including its Form 10-K for the year ended December 31, 2020 and its Form 10-Q for the
quarterly period ended September 30,
2021. Any forward-looking statements are made based on
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cautioned not to rely on any forward-looking statements made by
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Regeneron
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SOURCE Regeneron Pharmaceuticals, Inc.