Approval based on Phase 3 data showing Dupixent
significantly reduced severe asthma attacks and also improved lung
function and health-related quality of life for children
Data reinforce well-established safety profile of
Dupixent
TARRYTOWN, N.Y. and
PARIS, April 7,
2022 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc.
(NASDAQ: REGN) and Sanofi today announced that the European
Commission (EC) has expanded the marketing authorization for
Dupixent® (dupilumab) in the European Union. Dupixent is
now also approved in children aged 6 to 11 years as an add-on
maintenance treatment for severe asthma with type 2
inflammation characterized by raised blood eosinophils and/or
raised fractional exhaled nitric oxide (FeNO), who are inadequately
controlled with medium to high dose inhaled corticosteroids (ICS)
plus another medicinal product for maintenance treatment.
"Today's approval in Europe
recognizes the benefits of Dupixent in helping children living with
the profound effects of severe asthma, including unpredictable
asthma attacks, routine disruption to daily activities and the use
of systemic steroids that can impede children's growth," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "Dupixent is
the only treatment available that specifically blocks two key
drivers of type 2 inflammation, IL-4 and IL-13, which our trials
show plays a major role in childhood asthma, as well as in related
conditions such as chronic rhinosinusitis with nasal polyposis and
the often co-morbid condition, atopic dermatitis. In clinical
trials, Dupixent significantly reduced asthma attacks, helped
children breathe better and improved their health-related quality
of life. We also remain committed to investigating Dupixent in
other conditions where type 2 inflammation may significantly impact
patients' lives, including eosinophilic esophagitis, prurigo
nodularis and chronic spontaneous urticaria."
Asthma is one of the most common chronic diseases in children.
Up to 85% of children with asthma may have type 2 inflammation and
are more likely to have higher disease burden. Despite treatment
with current standard-of-care ICS and bronchodilators, these
children may continue to experience serious symptoms such as
coughing, wheezing and difficulty breathing. Severe asthma may
impact children's developing airways and cause potentially
life-threatening exacerbations. Children with severe asthma also
may require the use of multiple courses of systemic corticosteroids
that carry significant risks. Uncontrolled severe asthma can
interfere with day-to-day activities, like sleeping, attending
school and playing sports.
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. By demonstrating significant clinical benefit
together with a decrease in type 2 inflammation following IL-4 and
IL-13 blockade with Dupixent, the Dupixent Phase 3 clinical program
has established that IL-4 and IL-13 are key drivers of the type 2
inflammation that plays a major role in multiple related and often
co-morbid diseases for which Dupixent is approved including asthma,
atopic dermatitis and chronic rhinosinusitis with nasal polyposis
(CRSwNP), as well as investigational diseases such as eosinophilic
esophagitis and prurigo nodularis, which have been studied in Phase
3 trials.
"We are excited to bring the well-established safety and
efficacy profile of Dupixent to even younger patients living with
uncontrolled severe asthma in Europe. In addition to greatly reducing severe
asthma attacks and improving lung function, patients in our
clinical trials also reduced their oral corticosteroid use. This is
particularly meaningful as these are medicines that can carry
significant safety risks if used long term," said Naimish Patel, M.D. Head of Global Development,
Immunology and Inflammation at Sanofi. "This approval underscores
our continued commitment to bringing Dupixent to as many patients
as possible suffering from the negative effects of severe asthma
with the hope of improving their quality of life."
The EC decision is based on pivotal data from the Phase 3 VOYAGE
trial evaluating the efficacy and safety of Dupixent combined with
standard-of-care asthma therapy in 408 children with uncontrolled
moderate-to-severe asthma.
Two pre-specified populations with evidence of type 2
inflammation were evaluated for the primary analysis: 1) patients
with baseline blood eosinophils (EOS) ≥300 cells/μl (n=259) and 2)
patients with either baseline FeNO ≥20 parts per billion (ppb) or
baseline blood EOS ≥150 cells/μl (n=350). Patients who added
Dupixent to standard-of-care in these two groups, respectively,
experienced:
- Substantially reduced rates of severe asthma attacks, with a
65% and 59% average reduction over one year compared to placebo
(0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for
placebo, respectively).
- Improved lung function observed as early as two weeks and
sustained for up to 52 weeks, measured by percent predicted
FEV1 (FEV1pp).
-
- At 12 weeks, patients taking Dupixent improved their lung
function by 5.32 and 5.21 percentage points compared to placebo,
respectively.
- Improved asthma control, with 81% and 79% of patients reporting
a clinically meaningful improvement at 24 weeks, based on disease
symptoms and impact compared to 64% and 69% of placebo patients,
respectively.
- Improved health-related quality of life, with 73% and 73% of
patients reporting a clinically meaningful improvement at 24 weeks,
compared to 63% and 65% of placebo patients, respectively.
- Reduced systemic corticosteroid use by an average of 66% and
59% over one year compared to placebo (0.27 and 0.35 courses per
year for Dupixent vs. 0.81 and 0.86 for placebo,
respectively).
The safety results from the trial were generally consistent with
the known safety profile of Dupixent in patients aged 12 years and
older with uncontrolled moderate-to-severe asthma. The overall
rates of adverse events were 83% for Dupixent and 80% for placebo.
Adverse events that were more commonly observed with Dupixent
compared to placebo included injection site reactions (18%
Dupixent, 13% placebo), viral upper respiratory tract infections
(12% Dupixent, 10% placebo) and eosinophilia (7% Dupixent, 1%
placebo). Helminth infections were also more commonly observed with
Dupixent in patients aged 6 to 11 years and were reported in 2% of
Dupixent patients and 0% of placebo patients.
About the LIBERTY ASTHMA VOYAGE
Trial
The Phase 3 randomized, double-blind, placebo-controlled trial
evaluated the efficacy and safety of Dupixent (100 mg or 200 mg
every two weeks, based on weight tier) combined with
standard-of-care asthma therapy in 408 children aged 6 to 11 years
with uncontrolled moderate-to-severe asthma. More than 90% of
children in the trial had at least one concurrent atopic medical
condition such as allergic rhinitis and atopic dermatitis.
The primary endpoint was the annualized rate of severe asthma
exacerbations over one year, and the key secondary endpoint was the
change from baseline in percentage of predicted pre-bronchodilator
FEV1 (FEV1pp) at week 12. The
FEV1pp seeks to evaluate a patient's change in lung
function compared to their predicted lung function based on age,
height, sex and ethnicity to account for children's growing lung
capacity at different stages of development. Additional secondary
endpoints included responder rates for asthma control as measured
by a ≥0.5 improvement on the Asthma Control Questionnaire-7
Interviewer Administered (ACQ-7-IA; 7-point scale) and
health-related quality of life as measured by a ≥0.5 improvement on
the Pediatric Asthma Quality of Life Questionnaire with
Standardized Activities-Interviewer Administered (PAQLQ(S)-IA;
7-point scale).
About Dupixent
Dupixent is also approved in Europe, U.S., Japan and other countries around the world for
use in certain patients with asthma, specific patients with
moderate-to-severe atopic dermatitis as well as 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 400,000 patients have been treated globally.
Dupixent is an injection under the skin (subcutaneous injection)
at different injection sites. In the EU for pediatric patients aged
6 to 11 years, Dupixent dosing is based on weight tier (100 mg
every two weeks or 300 mg every four weeks for children ≥15 to
<30 kg, 200 mg every two weeks or 300 mg every four weeks for
children ≥30 to <60 kg and 200 mg every two weeks for children
≥60 kg) and is supplied as a pre-filled syringe. It is also
available as a pre-filled pen for adolescents (12 to 17 years) and
adults at 200 and 300 mg doses. 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. In children younger than 12 years of age,
Dupixent should be administered by a caregiver if given at
home.
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 InmazebTM
(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 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 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.
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).
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) as an add-on
maintenance treatment for children aged 6 to 11 years with severe
asthma with type 2 inflammation; 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 Regeneron's Products (such as
Dupixent) and Regeneron's Product Candidates; 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; 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
impacting Regeneron's Products, research and clinical programs, and
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
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research and development programs conducted by Regeneron and/or its
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and/or lead to advancement of product candidates to clinical
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financial projections or guidance and changes to the assumptions
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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. 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
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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 Forward-Looking
Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
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believes that the expectations reflected in such forward-looking
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Regeneron
Contacts:
Media
Relations
Ashleigh
Dixon
Tel: +1
914-374-2422
Ashleigh.Dixon@regeneron.com
|
Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443
Vesna.Tosic@regeneron.com
|
|
Sanofi Contacts:
Media
Relations
Sally
Bain
Tel: +1
781-264-1091
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
Arnaud
Delépine
Tel: +33 (0)6 73 69 36
93
arnaud.delepine@sanofi.com
Corentine
Driancourt
Tel: +33 (0)6 40 56
92
corentine.driancourt@sanofi.com
Felix
Lauscher
Tel: +1
908-612-7239
felix.lauscher@sanofi.com
Priya
Nanduri
priya.nanduri@sanofi.com
Nathalie
Pham
Tel: +33 (0)7 85 93 30
17
nathalie.pham@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.