TARRYTOWN, N.Y. and PARIS, May 20, 2022
/PRNewswire/ --
Dupixent is the first and only medicine indicated to treat
eosinophilic esophagitis in the United
States; approval granted more than two months ahead of FDA's
Priority Review action date
Dupixent 300 mg weekly significantly improved signs and
symptoms of eosinophilic esophagitis compared to placebo in a Phase
3 trial, underscoring the role of type 2 inflammation in this
complex disease
Eosinophilic esophagitis is a chronic, progressive
inflammatory disease driven by type 2 inflammation that damages the
esophagus and prevents it from working properly
Approval represents first indication for Dupixent in a
gastrointestinal disease and fourth disease indicated
overall
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the U.S. Food and Drug Administration (FDA) has
approved Dupixent® (dupilumab) 300 mg weekly to treat
patients with eosinophilic esophagitis (EoE) aged 12 years and
older, weighing at least 40 kg. With this approval, Dupixent
becomes the first and only medicine specifically indicated to treat
EoE in the United States. A
regulatory filing for EoE is under review by the European Medicines
Agency, and submissions to regulatory authorities in additional
countries are planned by the end of 2022.
"We have waited a long time for an FDA-approved treatment option
for eosinophilic esophagitis – an underdiagnosed and misunderstood
disease of the esophagus that can make it extremely challenging and
uncomfortable to eat and swallow," said Mary Jo Strobel, Executive Director at the
American Partnership for Eosinophilic Disorders (APFED). "Before
today, there were no approved treatments specifically for
eosinophilic esophagitis, resulting in many people needing to
maintain a strict diet and live in constant fear of food getting
stuck in their throat. We welcome therapeutic options that can
provide much-needed relief for these patients."
EoE is a chronic inflammatory disease driven by type 2
inflammation that damages the esophagus and prevents it from
working properly. For people with EoE, swallowing even small
amounts of food can be a painful and worrisome choking experience.
They are often left to contend with the frustration and anxiety of
a constantly evolving list of foods to avoid, a poor quality of
life and a higher risk of depression. In cases where EoE causes the
esophagus to narrow, forced and potentially painful dilation
(physical expansion) of the esophagus may be needed. In severe
cases, a feeding tube may be the only option to ensure proper
caloric intake and adequate nutrition. About 160,000 patients are
living with EoE in the U.S. These individuals are currently treated
with therapies not specifically approved for the disease, of whom
approximately 48,000 continue to experience symptoms despite
multiple treatments.
"It is gratifying that Dupixent, a medicine that we invented in
our laboratories, is now approved in yet another disease marked by
allergic or type 2 inflammation, namely eosinophilic esophagitis,"
said George D. Yancopoulos, M.D.,
Ph.D., President and Chief Scientific Officer at Regeneron, and a
principal inventor of Dupixent. "Eosinophilic esophagitis can be
debilitating for patients by inflaming and damaging the esophagus
and limiting the ability to eat normally. Dupixent is the first and
only medicine specifically indicated to treat eosinophilic
esophagitis in the United States,
and today's approval marks the fourth disease for which Dupixent is
now indicated, reinforcing the promise of targeting IL-4 and IL-13
to effectively treat diseases with underlying type 2
inflammation."
"Eating regularly throughout the day is essential, yet
significant difficulty swallowing food is a common symptom for
people living with eosinophilic esophagitis. This can be incredibly
upsetting and often leads to fear of pain or choking with every
meal, every day," said John Reed,
M.D., Ph.D., Global Head of Research and Development at Sanofi. "A
large unmet need exists for treatment options that can provide
meaningful symptom relief. Our Phase 3 clinical program showed that
Dupixent weekly improved the ability to swallow and reduced
inflammation in the esophagus, underscoring the role of type 2
inflammation in this complex disease. This is a landmark FDA
approval for patients and their caregivers who now have a new
option for treating this devastating disease."
The FDA approval is based on data from a Phase 3 trial with two
parts (Part A and Part B) evaluating the efficacy and safety
of Dupixent 300 mg weekly, compared to placebo, in patients aged 12
years and older with EoE, weighing at least 40 kg. After 24 weeks,
patients treated with Dupixent 300 mg weekly experienced the
following changes in Part A and Part B, respectively:
- 69% and 64% reduction in disease symptoms from baseline
compared to 32% and 41% for placebo. Disease symptoms were measured
by the Dysphagia Symptom Questionnaire (DSQ), where patients
receiving Dupixent experienced a 21.9- and 23.8-point clinically
meaningful improvement compared to 9.6- and 13.9-point improvement
for placebo.
- Approximately 10 times as many patients achieved histological
disease remission (peak esophageal intraepithelial eosinophil count
of ≤6 eos/high power field [hpf]) compared to placebo: 60% and 59%
compared to 5% and 6% of patients receiving placebo.
The safety results were generally consistent with the known
safety profile of Dupixent in its approved indications. Pooled
adverse events from Parts A and B that were more commonly (≥2%)
observed with Dupixent than placebo were injection site reactions
(38% Dupixent, 33% placebo), upper respiratory tract infections
(18% Dupixent, 10% placebo), arthralgia (2% Dupixent, 1% placebo)
and herpes viral infections (2% Dupixent, 1% placebo).
The FDA evaluated the Dupixent application 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.
About the Dupixent Eosinophilic
Esophagitis Trial
The Phase 3 randomized, double-blind, placebo-controlled trial
evaluated the efficacy and safety of Dupixent in patients aged 12
years and older with EoE. Part A enrolled 81 patients and evaluated
Dupixent 300 mg weekly (42 treated with Dupixent and 39 with
placebo). Part B enrolled 159 patients and evaluated Dupixent 300
mg weekly (80 with Dupixent and 79 with placebo).
At 24 weeks, the co-primary endpoints in Parts A and B assessed
patient-reported measures of difficulty swallowing (change from
baseline in the DSQ on a 0-84 scale) and esophageal inflammation
(proportion of patients achieving histological disease remission,
defined as peak esophageal intraepithelial eosinophil count of ≤6
eos/hpf).
About Dupixent
Dupixent is administered as an injection under the skin
(subcutaneous injection) at different injection sites. In patients
aged 12 years and older, weighing at least 40 kg, with EoE,
Dupixent is administered as a 300 mg dose with a pre-filled syringe
or pen every week. 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 aged 12 to 17 years, Dupixent should be
administered under the supervision of an adult.
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.
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 is also approved for use in certain patients with
atopic dermatitis, asthma or CRSwNP in different age populations in
a number of countries around the world, including the U.S.,
European Union and Japan. Dupixent
is currently approved for one or more of these indications in more
than 60 countries, and more than 400,000 patients have been treated
globally.
About Regeneron's
VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary
genetically engineered mouse platform endowed with a genetically
humanized immune system to produce optimized fully human
antibodies. When Regeneron's President and Chief Scientific Officer
George D. Yancopoulos was a graduate
student with his mentor Frederick W.
Alt in 1985, they were the first to envision making
such a genetically humanized mouse, and Regeneron has spent decades
inventing and developing VelocImmune and related
VelociSuite® technologies. Dr. Yancopoulos and
his team have used VelocImmune technology to create
approximately a quarter of all original, FDA-approved or authorized
fully human monoclonal antibodies currently available. This
includes Dupixent, REGEN-COV® (casirivimab and
imdevimab), Libtayo® (cemiplimab-rwlc),
Praluent® (alirocumab), Kevzara® (sarilumab),
Evkeeza® (evinacumab-dgnb) and 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), hand and foot atopic dermatitis (Phase 3), chronic
obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), pediatric eosinophilic esophagitis (Phase 3), bullous
pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic
spontaneous urticaria (Phase 3), chronic pruritis of unknown origin
(Phase 3), chronic inducible urticaria-cold (Phase 3), chronic
rhinosinusitis without nasal polyposis (Phase 3), allergic fungal
rhinosinusitis (Phase 3) and allergic bronchopulmonary
aspergillosis (Phase 3). 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
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.
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involve risks and uncertainties relating to future events and the
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Inc. ("Regeneron" or the "Company"), and actual events or
results may differ materially from these forward-looking
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"believe," "seek," "estimate," variations of such words, and
similar expressions are intended to identify such forward-looking
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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
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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
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acceptance, and commercial success of Regeneron's Products (such as
Dupixent) and Regeneron's Product Candidates and the impact of
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referenced in this press release, on any of the foregoing or any
potential regulatory approval of Regeneron's Products (such as
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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, pediatric
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
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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
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
Arnaud
Delepine
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
Tel: +1
617-764-6418
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.