TARRYTOWN, N.Y. and PARIS, May 31, 2022
/PRNewswire/ -- Dupixent would be the first and only medicine
specifically indicated to treat prurigo nodularis in the U.S., if
approved
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for Priority Review the supplemental Biologics License
Application (sBLA) for
Dupixent® Medical (dupilumab) to treat adults
with prurigo nodularis, a chronic skin disease that causes extreme
itch and inflammatory skin lesions (nodules). The target action
date for the FDA decision is September 30,
2022.
The sBLA is supported by data from two pivotal Phase 3 trials
evaluating the efficacy and safety of Dupixent in patients 18 years
and older with prurigo nodularis (PRIME2 and PRIME). Both
trials met the primary and key secondary endpoints, showing
Dupixent significantly improved disease signs and symptoms compared
to placebo, including reduction in itch and skin lesions. The
safety results from these trials were generally consistent with the
known safety profile of Dupixent in its approved dermatology
indications. The adverse event more commonly observed
with Dupixent was conjunctivitis.
The FDA grants Priority Review to therapies that have the
potential to provide significant improvements in the treatment,
diagnosis or prevention of serious conditions. Additional
regulatory filings around the world are also planned 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 Prurigo Nodularis
People with prurigo nodularis
experience intense, persistent itch, with thick skin lesions
(called nodules) that can cover most of the body. Prurigo nodularis
is often described as painful with burning, stinging and tingling
of the skin. The impact of uncontrolled prurigo nodularis on
quality of life is one of the highest among inflammatory skin
diseases due to the extreme itch and is comparable to other
debilitating chronic diseases that can negatively affect mental
health, activities of daily living and social interactions.
High-potency topical steroids are commonly prescribed but are
associated with safety risks if used long-term. There are
approximately 75,000 people in the U.S. who are unable to control
their disease with systemic therapy and are most in need of a
treatment option.
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. 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 asthma,
atopic dermatitis, chronic rhinosinusitis with nasal polyposis
(CRSwNP) and eosinophilic esophagitis, as well as investigational
diseases such as prurigo nodularis.
Dupixent is approved for use in certain patients with atopic
dermatitis, asthma, CRSwNP or eosinophilic esophagitis in different
age populations in a number of countries around the world. Dupixent
is currently approved across these indications in the U.S.
and for one or more of these indications in the European
Union and Japan and more than
60 countries. More than 400,000 patients have been 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 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 one in five 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 in Phase 3
trials, including pediatric atopic dermatitis (6 months to 5 years
of age), prurigo nodularis, pediatric eosinophilic esophagitis,
hand and foot atopic dermatitis, chronic inducible urticaria-cold,
chronic spontaneous urticaria, chronic pruritis of unknown origin,
chronic obstructive pulmonary disease with evidence of type 2
inflammation, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, allergic bronchopulmonary
aspergillosis 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 years of age 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
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 at least 88 pounds (40 kg).
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" 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 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. 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:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, 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, sometimes
with blurred vision, high count of a certain white blood cell
(eosinophilia), trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
- Eosinophilic esophagitis: injection site reactions,
upper respiratory tract infections, cold sores in your mouth or on
your lips, 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 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 under 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
nearly 35 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
We 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 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
marketed or otherwise commercialized by Regeneron and/or its
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
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 prurigo nodularis; 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 prurigo nodularis
(including potential approval by the U.S. Food and Drug
Administration based on the supplemental Biologics License
Application discussed in this press release), pediatric atopic
dermatitis, hand and foot atopic dermatitis, chronic obstructive
pulmonary disease with evidence of type 2 inflammation, pediatric
eosinophilic esophagitis, bullous pemphigoid, chronic spontaneous
urticaria, chronic pruritis of unknown origin, chronic inducible
urticaria-cold, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, allergic bronchopulmonary
aspergillosis, and other potential indications; uncertainty of the
utilization, market acceptance, and commercial success of
Regeneron's Products (such as Dupixent) 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 or any potential regulatory approval of
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Candidates; the ability of Regeneron's collaborators, licensees,
suppliers, or other third parties (as applicable) to perform
manufacturing, filling, finishing, packaging, labeling,
distribution, and other steps related to Regeneron's Products and
Regeneron's Product Candidates; the ability of Regeneron to manage
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
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
Products and Regeneron's Product Candidates, including without
limitation Dupixent; ongoing regulatory obligations and oversight
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business, including those relating to patient privacy; the
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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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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-COV® (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 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
Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the
quarterly period ended March 31,
2022. 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
Regeneron. Regeneron does not undertake any obligation to update
(publicly or otherwise) any forward-looking statement, including
without limitation any financial projection or guidance, whether as
a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and
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Regeneron
Contacts:
Media
Relations
Hannah
Kwagh
Tel: +1
914-847-6314
Hannah.Kwagh@regeneron.com
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Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443
Vesna.Tosic@regeneron.com
|
|
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Sanofi
Contacts:
Media
Relations
Sally Bain
Tel: +1
617-834-6026
Sally.Bain@sanofi.com
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Investor
Relations
Eva Schaefer-Jansen
Tel: +33 7 86 80 56
39
eva.schaefer-jansen@sanofi.com
|
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Arnaud Delepine
Tel: +33 (0)6 73 69 36
93
arnaud.delepine@sanofi.com
|
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Corentine Driancourt
Tel: +33 (0)6 40 56
92
corentine.driancourt@sanofi.com
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Felix Lauscher
Tel: +1
908-612-7239
felix.lauscher@sanofi.com
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Priya Nanduri
priya.nanduri@sanofi.com
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Nathalie
Pham Tel: +33 (0)7 85 93 30
17
nathalie.pham@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.