TARRYTOWN, N.Y. and
PARIS, Oct.
22, 2021 /PRNewswire/ --
Pivotal trial met primary and all key secondary
endpoints
Dupixent significantly reduced itch at 12 weeks, and nearly
three times as many Dupixent patients experienced reductions in
both itch and skin lesions at 24 weeks
Prurigo nodularis, the sixth disease where Dupixent has
demonstrated positive Phase 3 results, is a chronic skin condition
that causes extreme itch and inflammatory skin lesions
(nodules)
Data reinforce impact of targeting IL-4 and IL-13, key and
central drivers of type 2 inflammation, to address itch and skin
lesions
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced positive pivotal Phase 3 results from a trial evaluating
Dupixent® (dupilumab) in adults with uncontrolled
prurigo nodularis, a chronic type 2 inflammatory skin disease that
causes extreme itch and skin lesions. The trial met its primary and
all key secondary endpoints, showing that Dupixent significantly
reduced itch and skin lesions compared to placebo in this
investigational setting. The impact of uncontrolled prurigo
nodularis on quality of life is one of the highest among
inflammatory skin diseases with intense, chronic itch.
"Prurigo nodularis is an underdiagnosed disease with immense
physical and emotional burden for the 74,000 people in the U.S. who
are unable to control their disease with topical steroids and
otherwise do not have an approved treatment option," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "These
patients are left to cope with severe itching and painful nodules
that, in turn, significantly impair one's quality of life with many
resorting to immunosuppressants and some to antidepressants. These
results show – for the first time in a Phase 3 prurigo nodularis
trial – that a systemic medicine was able to address the most
debilitating symptoms such as itch without broadly suppressing the
immune system, building on the promise of Dupixent in a broad range
of serious dermatologic, respiratory and gastrointestinal
diseases."
People with prurigo nodularis experience intense, persistent
itch, with thick skin lesions (called nodules) that can cover most
of the body. It is often described as painful with burning,
stinging and tingling of the skin. The debilitating signs and
symptoms of prurigo nodularis can negatively impact health-related
quality of life, including mental health, activities of daily
living and social interactions. There are no approved systemic
treatments for prurigo nodularis. High-potency topical steroids are
commonly used, which are associated with safety risks if used
long-term.
"We are encouraged that patients in this trial experienced a
significant reduction in itch and skin lesions, especially given
that prior to enrollment nearly all patients had severe itch and
nearly 40% had 100 or more nodules covering their body," said
John Reed, M.D., Ph.D., Global Head
of Research and Development at Sanofi. "These data are an important
step forward in furthering our knowledge of the role that targeting
IL-4 and IL-13 can play in the treatment of skin diseases that
cause extreme itch. We are committed to continuing to leverage the
robust Dupixent clinical program to transform the understanding of
the science behind a number of type 2 inflammatory diseases and
look forward to presenting the full results at a future medical
congress."
In the Phase 3 PRIME2 trial, topline results comparing Dupixent
(n=78) to placebo (n=82) showed:
- 37% of Dupixent patients experienced a clinically meaningful
reduction in itch from baseline compared to 22% of placebo patients
(p=0.0216) at week 12, the primary endpoint.
- At week 24, nearly three times as many Dupixent patients
experienced a clinically meaningful reduction in itch from
baseline: 58% of Dupixent patients compared to 20% of placebo
patients (p<0.0001).
- At week 24, nearly three times as many Dupixent patients
achieved clear or almost clear skin: 45% of Dupixent patients
compared to 16% of placebo patients (p<0.0001).
- Dupixent patients experienced significantly greater
improvements in measures of health-related quality of life, skin
pain and symptoms of anxiety and depression.
The safety results of the trial were generally consistent with
the known safety profile of Dupixent in its approved indications.
The occurrences of treatment-emergent adverse events were generally
similar between Dupixent and placebo groups (57% [44/77] Dupixent,
51% [42/82] placebo). Rates of conjunctivitis (6% [5/77] Dupixent,
0% [0/82] placebo) and herpes viral infections (6% [5/77] Dupixent,
0% [0/82] placebo) were similar to what was previously observed in
atopic dermatitis trials, and there was a numerically lower rate of
skin infections observed with Dupixent (5% [4/77] Dupixent, 9%
[7/82] placebo). Additionally, 3% (2/77) of Dupixent patients and
30% (25/82) of placebo patients discontinued prior to week 24.
An additional trial in the LIBERTY-PN PRIME clinical program,
PRIME, is fully enrolled. PRIME has a similar trial design and is
expected to read out in in the first half of 2022. Regeneron and
Sanofi plan to begin regulatory submissions in 2022.
The potential use of Dupixent in prurigo nodularis is currently
under clinical development, and the safety and efficacy have not
been fully evaluated by any regulatory authority.
About the Trial
PRIME2, part of the LIBERTY-PN PRIME clinical program, is a
randomized, Phase 3, double-blind, placebo-controlled trial that
evaluated the efficacy and safety of Dupixent in 160 adults with
prurigo nodularis inadequately controlled with topical prescription
therapies or with whom those therapies were not advisable. During
the 24-week treatment period, patients received Dupixent or placebo
every two weeks with or without topical treatments (low- or
medium-dose topical corticosteroids or topical calcineurin
inhibitors were continued if patients were using these treatments
at randomization).
The primary endpoint evaluated the proportion of patients with
clinically meaningful improvement in itch at week 12 (measured by a
≥4-point reduction in Worst-Itch Numeric Rating Scale [WI-NRS] of
0-10). Key secondary endpoints included the proportion of patients
with clinically meaningful improvement in itch at week 24 and the
proportion of patients with clear or almost clear skin at week 24
(measured by a score of 0 or 1 on the Investigator's Global
Assessment PN-Stage [IGA PN-S] 0-4 scale). Additional secondary
endpoints included health-related quality of life (measured by
change in baseline according to the 0-30 point Dermatology Life
Quality Index), skin pain (measured by change in baseline on a 0-10
scale), and symptoms of anxiety and depression (measured by change
in baseline according to a 0-42 Hospital Anxiety and Depression
scale).
The average age in the trial was 49 years and 64% were female.
Approximately 33% of patients were Asian, 13% were Latino/Hispanic
and 5% were Black/African American. In the trial, 46% of patients
had at least one coexisting type 2 inflammatory disease. About 24%
of patients enrolled had prior history with systemic
(non-steroidal) immunosuppressants and 11% had been treated with
antidepressants.
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 and is not
an immunosuppressant. 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
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,
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.
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
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ability to manage its supply chain, net product sales of products
marketed or otherwise commercialized by Regeneron and/or its
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therapeutic applications of Regeneron's Products and product
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
limitation Dupixent® (dupilumab); the likelihood,
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launch of Regeneron's Product Candidates and new indications for
Regeneron's Products, such as Dupixent for the treatment of
prurigo nodularis, chronic obstructive pulmonary disease with
evidence of type 2 inflammation, pediatric atopic dermatitis,
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 commercial success of
Regeneron's Products and Regeneron's Product Candidates and the
impact of studies (whether conducted by Regeneron or others and
whether mandated or voluntary), including the study discussed in
this press release, on any of the foregoing or any potential
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supply chains for multiple products and product candidates; 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 Regeneron's Products and Regeneron's Product Candidates
in clinical trials; determinations by regulatory and administrative
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ability to continue to develop or commercialize Regeneron's
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impacting Regeneron's Products, research and clinical programs, and
business, including those relating to patient privacy; the
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insurance programs, health maintenance organizations, pharmacy
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
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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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of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
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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 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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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, 2020 and its Form 10-Q
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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Regeneron
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