Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
updated the label for Dupixent® (dupilumab) in atopic dermatitis,
adding efficacy and safety data for patients aged 12 years and
older with atopic dermatitis with uncontrolled moderate-to-severe
hand and/or foot involvement. These Phase 3 data are from the first
and only trial evaluating a biologic specifically for this
difficult-to-treat population and have also been added to the
Dupixent label in the European Union, with regulatory submissions
underway in additional countries.
“We rely heavily on our hands and feet throughout the day,
making atopic dermatitis particularly disruptive for patients who
experience constant itch and painful cracking and bleeding skin
lesions on these critical areas of the body,” said George D.
Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief
Scientific Officer at Regeneron, and a principal inventor of
Dupixent. “Dupixent has been used to treat hundreds of thousands of
patients with moderate-to-severe atopic dermatitis around the world
since its initial U.S. approval in 2017, and we are pleased that
Dupixent is now the first biologic with data in the label
supporting its use in this particularly challenging subset of the
disease.”
“Living with atopic dermatitis on your most essential body areas
like the hands and feet can make daily activities including walking
and writing incredibly burdensome even in the case where disease
symptoms are mild elsewhere. Unfortunately, treating atopic
dermatitis on the hands and feet has historically been difficult
and there have been no Phase 3 trials evaluating a biologic in this
population of patients,” said Naimish Patel, M.D., Head of Global
Development, Immunology and Inflammation at Sanofi. “Having these
data added for this difficult-to-treat population is important for
physicians looking for tools to treat these patients and reinforces
the already well-established efficacy and safety of Dupixent in
atopic dermatitis overall.”
The label update is based on data from the Phase 3
LIBERTY-AD-HAFT trial. In the trial, patients received Dupixent
(n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg
based on body weight) or placebo (n=66). At 16 weeks, patients
treated with Dupixent experienced the following:
- 40% achieved clear or almost clear skin on hands and feet
compared to 17% with placebo, the primary endpoint
- 52% saw a clinically meaningful reduction in itch on hands and
feet compared to 14% with placebo, the key secondary endpoint
The safety results were generally consistent with the known
safety profile of Dupixent in atopic dermatitis. Most common
adverse events (AEs) observed with Dupixent (≥1%) in atopic
dermatitis include injection site reactions, conjunctivitis,
blepharitis, oral herpes, keratitis, eye pruritus, other herpes
simplex virus infection, dry eye and eosinophilia.
About the Clinical Trial The Phase 3
double-blind, placebo-controlled trial, LIBERTY-AD-HAFT, evaluated
the efficacy and safety of Dupixent in 133 adult and adolescent
(aged 12 to 17 years) patients with atopic dermatitis with
moderate-to-severe hand and/or foot involvement who had an
inadequate response or intolerance to topical corticosteroids.
Patients with hand and foot disease predominantly driven by
allergic or irritant contact dermatitis were excluded from the
trial.
The primary endpoint evaluated the proportion of patients with
clear or almost clear skin of hand and feet eczema at 16 weeks, as
measured by a score of 0 or 1 on the Investigator Global Assessment
Scale. The key secondary endpoint measured the proportion of
patients with improvement in itch on hands and feet from baseline
(measured by a ≥4-point reduction in Peak-Pruritis Numeric Rating
Scale [PP-NRS] on a 0-10 scale) at 16 weeks.
About DupixentDupixent, 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. The Dupixent development program
has shown significant clinical benefit and a decrease in type 2
inflammation in Phase 3 trials, establishing that IL-4 and IL-13
are key and central drivers of the type 2 inflammation that plays a
major role in multiple related and often co-morbid diseases. These
diseases include approved indications for Dupixent, such as atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP), eosinophilic esophagitis (EoE) and prurigo nodularis.
Dupixent has received regulatory approvals in one or more
countries around the world for use in certain patients with atopic
dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different
age populations. Dupixent is currently approved for one or more of
these indications in more than 60 countries, including
in Europe, the U.S. and Japan. More than
800,000 patients are being treated with Dupixent 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 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 a substantial
proportion of all original, FDA-approved or authorized fully human
monoclonal antibodies. This includes REGEN-COV® (casirivimab
and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and Inmazeb® (atoltivimab,
maftivimab and odesivimab-ebgn).
Dupilumab Development ProgramDupilumab is being
jointly developed by Regeneron and Sanofi under a global
collaboration agreement. To date, dupilumab has been studied across
more than 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 in Phase 3
trials, including pediatric EoE, chronic spontaneous urticaria,
chronic pruritus of unknown origin, chronic obstructive pulmonary
disease with evidence of type 2 inflammation and bullous
pemphigoid. 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 adults and children 6 months of age and older with
moderate-to-severe eczema (atopic dermatitis or AD) 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 months of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe eosinophilic or oral steroid dependent asthma in
adults and children 6 years of age 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.
- to treat adults and children 12 years of age and older, who
weigh at least 88 pounds (40 kg), with eosinophilic esophagitis
(EoE). It is not known if DUPIXENT is safe and effective in
children with eosinophilic esophagitis under 12 years of age and
who weigh less than 88 pounds (40 kg).
- to treat adults with prurigo nodularis (PN). It is not known if
DUPIXENT is safe and effective in children with prurigo nodularis
under 18 years of age.
IMPORTANT SAFETY INFORMATION
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” right before and during treatment 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,
chronic rhinosinusitis with nasal polyposis, eosinophilic
esophagitis, or prurigo nodularis 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. DUPIXENT can cause allergic
reactions that can sometimes be severe. Stop using
DUPIXENT and tell your healthcare provider or get emergency help
right away if you get any of the following signs or symptoms:
breathing problems or wheezing, swelling of the face, lips, mouth,
tongue or throat, fainting, dizziness, feeling lightheaded, fast
pulse, fever, hives, joint pain, general ill feeling, itching, skin
rash, swollen lymph nodes, nausea or vomiting, or cramps in your
stomach-area.
- Eye problems. Tell your healthcare provider if
you have any new or worsening eye problems, including eye pain or
changes in vision, such as blurred vision. Your healthcare provider
may send you to an ophthalmologist for an exam if
needed.
- 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, chest pain, worsening shortness of
breath, a feeling of pins and needles or numbness of your arms or
legs, or persistent fever.
- Joint aches and pain. Some people who use
DUPIXENT have had trouble walking or moving due to their joint
symptoms, and in some cases needed to be hospitalized. Tell your
healthcare provider about any new or worsening joint symptoms. Your
healthcare provider may stop DUPIXENT if you develop joint
symptoms.
The most common side effects include:
- Eczema: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, dry eye, cold sores in your mouth or
on your lips, and high count of a certain white blood cell
(eosinophilia).
- Asthma: injection site reactions, high count
of a certain white blood cell (eosinophilia), pain in the throat
(oropharyngeal pain), and parasitic (helminth)
infections.
- Chronic Rhinosinusitis with Nasal Polyposis:
injection site reactions, eye and eyelid inflammation, including
redness, swelling, and itching, sometimes with blurred vision, high
count of a certain white blood cell (eosinophilia), gastritis,
joint pain (arthralgia), trouble sleeping (insomnia), and
toothache.
- Eosinophilic Esophagitis: injection site
reactions, upper respiratory tract infections, cold sores in your
mouth or on your lips, and joint pain (arthralgia).
- Prurigo Nodularis: eye and eyelid
inflammation, including redness, swelling, and itching, sometimes
with blurred vision, herpes virus infections, common cold symptoms
(nasopharyngitis), dizziness, muscle pain, and diarrhea.
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 by your healthcare provider.
It’s an injection given under the skin (subcutaneous injection).
Your healthcare provider will decide if you or your caregiver can
inject DUPIXENT. Do not try to prepare and inject
DUPIXENT until you or your caregiver have been trained by your
healthcare provider. In children 12 years of age and older, it’s
recommended DUPIXENT be administered by or under supervision of an
adult. In children 6 months to less 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, develops and
commercializes life-transforming medicines for people with serious
diseases. Founded and led for over 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and 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, 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 more information, please visit www.Regeneron.com or follow
@Regeneron on LinkedIn.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people's lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ:
SNY.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
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and uncertainties include, among others, the nature, timing, and
possible success and therapeutic applications of products marketed
or otherwise commercialized by Regeneron and/or its collaborators
or licensees (collectively, “Regeneron’s Products”) and product
candidates being developed by Regeneron and/or its collaborators or
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 hand and foot dermatitis; 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 studies discussed or
referenced in this press release, on any of the foregoing; 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 pediatric eosinophilic esophagitis, chronic spontaneous
urticaria, chronic pruritus of unknown origin, chronic obstructive
pulmonary disease with evidence of type 2 inflammation, bullous
pemphigoid, and other potential indications; the ability of
Regeneron’s collaborators, licensees, suppliers, or other third
parties (as applicable) to perform manufacturing, filling,
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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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to which the results from the research and development programs
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replicated in other studies and/or lead to advancement of product
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Regeneron to meet any of its financial projections or guidance and
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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), other litigation and other proceedings and government
investigations relating to the Company and/or its operations, the
ultimate outcome of any such proceedings and investigations, and
the impact any of the foregoing may have on Regeneron’s business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron’s filings with the U.S. Securities and Exchange
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2022 and its Form 10-Q for the quarterly period ended September 30,
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does not undertake any obligation to update (publicly or otherwise)
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Disclaimers or Forward-Looking Statements This press
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Forward-looking statements are statements that are not historical
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Regeneron
Contacts:Media RelationsHannah
KwaghTel: +1 914-847-6314 Hannah.Kwagh@regeneron.com |
Investor
RelationsVesna TosicTel: +1
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Sanofi
Contacts:Media RelationsSally
BainTel: +1 617-834-6026Sally.Bain@sanofi.com |
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