Dupixent significantly reduced itch and skin lesions compared
to placebo in direct-to-Phase 3 program consisting of two pivotal
trials
About 75,000 adults in the U.S. living with prurigo nodularis
are most in need of new treatment options
Approval represents the second dermatology indication for
Dupixent and fifth disease indication overall in the U.S.
TARRYTOWN, N.Y. and PARIS, Sept. 28,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that the U.S. Food and
Drug Administration (FDA) has approved Dupixent®
(dupilumab) for the treatment of adult patients with prurigo
nodularis. With this approval, Dupixent becomes the first and only
medicine specifically indicated to treat prurigo nodularis in the
U.S. Prurigo nodularis is a chronic, debilitating skin disease with
underlying type 2 inflammation and its impact on quality of life is
one of the highest among inflammatory skin diseases. The FDA
evaluated the Dupixent application for prurigo nodularis under
Priority Review, which is granted to therapies that have the
potential to provide significant improvements in the treatment,
diagnosis or prevention of serious conditions.
"Patients living with prurigo nodularis must often contend with
dozens, if not hundreds, of itchy and painful nodules covering
their body and have not had an approved treatment option for their
disease," said George D.
Yancopoulos, M.D., Ph.D., President and Chief Scientific
Officer at Regeneron, and a principal inventor of Dupixent.
"Dupixent has already transformed the treatment landscape of
several diseases driven by type 2 inflammation – including atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and
eosinophilic esophagitis – and been prescribed to more than half a
million patients around the world for its approved indications.
With this approval, those suffering with prurigo nodularis finally
have a medicine to address the debilitating signs and symptoms of
the disease."
"Until today, there were limited treatment options to manage the
relentless itch and associated sensations of burning and stinging
skin that can negatively impact the lives of patients struggling
with prurigo nodularis," said Naimish
Patel, M.D, Head of Global Development, Immunology and
Inflammation at Sanofi. "Dupixent has the potential to transform
the standard-of-care for prurigo nodularis patients by alleviating
the key hallmarks of the disease, such as reducing itch and
achieving clearer skin. With Dupixent now approved in two diseases
in dermatology where type 2 inflammation is a central driver, we
look forward to further evaluating the potential of inhibiting IL-4
and IL-13 in other chronic skin diseases."
The FDA approval is based on data from two Phase 3 trials,
PRIME and PRIME2, evaluating the efficacy and safety of
Dupixent in adults with prurigo nodularis. Efficacy in these trials
assessed the proportion of subjects with clinically meaningful
reduction in itch, clearing of skin, or both:
- About three times as many Dupixent patients (60% and 58%)
experienced a clinically meaningful reduction in itch from baseline
at 24 weeks, compared to 18% and 20% for placebo, the primary
endpoint in PRIME
- 44% and 37% of Dupixent patients experienced a clinically
meaningful reduction in itch from baseline at 12 weeks, compared to
16% and 22% for placebo, the primary endpoint in PRIME2
- More than twice as many Dupixent patients (48% and 45%)
achieved clear or almost clear skin at 24 weeks, compared to 18%
and 16% for placebo
- More than three times as many Dupixent patients (39% and 32%)
experienced both a clinically meaningful reduction in itch and
clear or almost clear skin, compared to 9% and 9% of placebo
patients at 24 weeks
The safety results of the trial were generally consistent with
the known safety profile of Dupixent in its approved dermatology
indication. The most common adverse events (≥2%) from pooled PRIME
and PRIME2 data more frequently observed with Dupixent than placebo
were nasopharyngitis (5% Dupixent, 2% placebo), conjunctivitis (4%
Dupixent, 1% placebo), herpes infection (3% Dupixent, 0% placebo),
dizziness (3% Dupixent, 1% placebo), muscle pain (3% Dupixent, 1%
placebo), and diarrhea (3% Dupixent, 1% placebo).
A regulatory filing for prurigo nodularis is under review by the
European Medicines Agency, and submissions to regulatory
authorities in additional countries are also planned in 2022.
About Prurigo Nodularis
People with prurigo nodularis experience intense, persistent
itch with thick skin lesions (called nodules) that can cover most
of the body. The disease is often painful, with burning, stinging
and tingling of the skin. The impact of 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 about
75,000 adults in the U.S. living with prurigo nodularis and are
most in need of new treatment options.
About the Dupixent Prurigo Nodularis Trials
The PRIME and PRIME2 Phase 3 double-blind, placebo-controlled
trials evaluated the efficacy and safety of Dupixent in 311 adults
with uncontrolled prurigo nodularis.
In PRIME and PRIME2, the primary endpoint evaluated the
proportion of patients with clinically meaningful improvement in
itch from baseline (measured by a ≥4-point reduction in Worst-Itch
Numeric Rating Scale [WI-NRS] on a 0-10 scale) at 24 and 12 weeks,
respectively. Additional endpoints included the proportion of
patients with clear or almost clear skin of nodules at 24 weeks
(measured by a score of 0 or 1 on the Investigator's Global
Assessment PN-Stage [IGA PN-S] on a 0-4 scale), and the proportion
of patients who achieved a clinically meaningful response in both
WI-NRS and IGA PN-S.
About Dupixent
Dupixent is administered as an injection under the skin
(subcutaneous injection) at different injection sites. In patients
aged 18 years and older with prurigo nodularis, Dupixent 300 mg is
administered with a pre-filled syringe or pre-filled pen every two
weeks following an initial loading dose. Dupixent is intended for
use under the guidance of a healthcare professional and can be
given in a clinic or at home by self-administration after training
by a healthcare professional.
Regeneron and Sanofi are committed to helping patients in the
U.S. who are prescribed Dupixent gain access to the medicine and
receive the support they may need with the DUPIXENT
MyWay® program. For more information, please call
1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.
Dupixent has received regulatory approvals in one or more
countries around the world for use in certain patients with atopic
dermatitis, asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP), eosinophilic esophagitis (EoE) or prurigo nodularis in
different age populations. Dupixent is currently approved across
these indications in the U.S. and for one or more of these
indications in more than 60 countries, including in the European
Union and Japan. More than 500,000
patients have been treated with Dupixent globally.
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 prurigo
nodularis, atopic dermatitis, asthma, CRSwNP and EoE.
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 approximately one in five
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 Program
Dupilumab 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 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.
IMPORTANT SAFETY INFORMATION &
INDICATIONS
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:
- Atopic Dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching,
sometimes with blurred vision, 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 under 12 years of age, DUPIXENT should be given
by a caregiver.
Please see accompanying full Prescribing Information including Patient Information.
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 at least 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.
About Regeneron Regeneron is a leading
biotechnology company that invents, develops and commercializes
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 more information, 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; 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; 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 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, bullous
pemphigoid, and other potential indications; 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
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business, including those relating to patient privacy; the
availability and extent of reimbursement of Regeneron's Products
from third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
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
more cost effective than, Regeneron's Products and Regeneron's
Product Candidates; the extent to which the results from the
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
trials, therapeutic applications, or regulatory approval;
unanticipated expenses; the costs of developing, producing, and
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financial projections or guidance and changes to the assumptions
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) 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 June 30, 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
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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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Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
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(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron).
Sanofi Disclaimers or Forward-Looking
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amended. Forward-looking statements are statements that are not
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Forward-looking statements are generally identified by the words
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Regeneron
Contacts:
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Sanofi
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SOURCE Regeneron Pharmaceuticals, Inc.