TARRYTOWN, N.Y. and
PARIS, Feb.
26, 2022 /PRNewswire/ --
Dupixent 300 mg weekly is the only biologic medicine to show
positive, clinically meaningful Phase 3 results in adults and
adolescents with eosinophilic esophagitis
Eosinophilic esophagitis is a chronic, progressive type 2
inflammatory disease that damages the esophagus and prevents it
from working properly
U.S. and global regulatory filings are planned in
2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced positive detailed results from a second Phase 3 trial
that showed Dupixent® (dupilumab) 300 mg weekly
significantly improved the signs and symptoms of eosinophilic
esophagitis (EoE) at 24 weeks compared to placebo in patients 12
years and older. These pivotal data will be presented today at the
2022 American Academy of Allergy, Asthma and Immunology (AAAAI)
Annual Meeting during a late-breaking oral abstract session.
"Eosinophilic esophagitis can greatly impact a person's ability
to eat normally, and physicians rely on invasive medical procedures
to monitor and, in more serious cases, stretch the esophagus," said
Evan S. Dellon, M.D., M.P.H.,
Professor of Gastroenterology and Hepatology at the University of North Carolina School of Medicine and
co-principal investigator of the trial. "Currently, there are no
FDA-approved treatment options that address the underlying drivers
of this disease. The data from this trial showed dupilumab taken
weekly not only improved patients' ability to swallow, but also
reduced markers of type 2 inflammation in the esophagus, indicating
its potential to address a major underlying cause of eosinophilic
esophagitis."
Topline results from the Dupixent 300 mg weekly arm of the
trial, which enrolled 80 patients in the Dupixent group and 79
patients in the placebo group, were announced in October 2021 and confirm results from the first
Phase 3 trial. The co-primary endpoints at 24 weeks assessed
patient-reported measures of difficulty swallowing (change from
baseline in the 0-84 Dysphagia Symptom Questionnaire, or DSQ), and
esophageal inflammation (proportion of patients achieving
histological disease remission, defined as peak esophageal
intraepithelial eosinophil count of ≤6 eos/high power field
[hpf]).
Data presented at the 2022 AAAAI Annual Meeting showed that
patients treated with Dupixent 300 mg weekly experienced the
following changes by week 24 compared to placebo:
- 64% reduction in disease symptoms from baseline compared to 41%
for placebo (p=0.0008). Patients receiving Dupixent experienced a
23.78 point improvement on the DSQ, compared to a 13.86 point
improvement for placebo (p<0.0001); baseline DSQ scores were
approximately 38 and 36 points, respectively.
- Nearly 10 times as many patients receiving Dupixent achieved
histological disease remission: 59% of patients achieved
histological disease remission compared to 6% of patients receiving
placebo (p<0.0001); mean baseline peak levels were 89 and 84
eos/hpf, respectively.
The safety results of the trial were generally consistent with
the known safety profile of Dupixent in its approved indications.
For the 24-week treatment period (Dupixent n=80, placebo n=78),
overall rates of adverse events were 84% for Dupixent 300 mg weekly
and 71% for placebo. Adverse events that were more commonly (≥5%)
observed with Dupixent every week included injection site reactions
(38% Dupixent, 33% placebo), fever (6% Dupixent, 1% placebo),
sinusitis (5% Dupixent, 0% placebo), COVID-19 (5% Dupixent, 0%
placebo) and hypertension (5% Dupixent, 1% placebo). No imbalance
was observed in rates of treatment discontinuation due to adverse
events between Dupixent (3%) and placebo (3%) groups prior to week
24.
The trial also found that significantly more patients treated
with Dupixent 300 mg every two weeks reduced their esophageal
eosinophilic count to the normal range compared to placebo;
however, there was not a significant improvement in dysphagia
symptoms. Detailed results on the every two week dosing will be
presented at an upcoming congress.
Data from the clinical trial program have been submitted to the
U.S. Food and Drug Administration (FDA). Global regulatory filings
in other countries are also planned in 2022.
In September 2020, the U.S. FDA
granted Breakthrough Therapy designation to Dupixent for the
treatment of patients 12 years and older with EoE. Dupixent was
also granted Orphan Drug designation for the potential treatment of
EoE in 2017. The potential use of Dupixent in EoE is currently
under clinical development, and the safety and efficacy have not
been fully evaluated by any regulatory authority.
About Eosinophilic Esophagitis (EoE)
EoE is a chronic, progressive type 2 inflammatory disease that
damages the esophagus and prevents it from working properly. For
patients with EoE, swallowing the smallest amount of food or taking
a sip of water can be a painful and worrisome choking experience.
This disease can also cause narrowing of the esophagus and dilation
(physical expansion) of the esophagus may be needed, which is often
painful. In severe cases, a feeding tube is the only option to
ensure proper caloric intake and weight gain. There are
approximately 160,000 patients in the U.S. living with EoE who are
currently treated, of whom approximately 48,000 have failed
multiple treatments.
About the Dupixent Eosinophilic Esophagitis Trial
The Phase 3 randomized, double-blind, placebo-controlled trial
evaluated the efficacy and safety of Dupixent in adolescents and
adults with EoE. This second trial (Part B) enrolled 240 patients
aged 12 years and older with EoE, as determined by histological and
patient-reported measures. Following the first Phase 3 trial (Part
A), in which Dupixent 300 mg weekly was evaluated compared to
placebo, the second confirmatory trial evaluated Dupixent 300 mg
weekly or every two weeks compared to placebo for a 24-week
treatment period.
The clinical trial program is ongoing, with patients from the
first and second trials continuing into a 28-week long-term
extension trial (Part C). Full results from this trial will be
available later this year.
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. IL-4 and IL-13 are key and central drivers of
the type 2 inflammation that plays a major role in atopic
dermatitis, asthma and chronic rhinosinusitis with nasal polyposis
(CRSwNP).
Dupixent is currently approved in the U.S., Europe, Japan
and other countries around the world for use in specific patients
with moderate-to-severe atopic dermatitis, as well as certain
patients with asthma or 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 350,000
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 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, including
eosinophilic esophagitis (Phase 3), pediatric atopic dermatitis (6
months to 5 years of age, Phase 3), chronic rhinosinusitis without
nasal polyposis (Phase 3), chronic obstructive pulmonary disease
with evidence of type 2 inflammation (Phase 3), prurigo nodularis
(Phase 3), chronic spontaneous urticaria (Phase 3), bullous
pemphigoid (Phase 3), chronic inducible urticaria-cold (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 over 30 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
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Regeneron and/or its collaborators or licensees (collectively,
"Regeneron's Products"), and the global economy; the nature,
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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
programs now underway or planned, including without limitation
Dupixent® (dupilumab) for the treatment of
eosinophilic esophagitis; 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 eosinophilic
esophagitis, chronic obstructive pulmonary disease with evidence of
type 2 inflammation, pediatric atopic dermatitis, 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; 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 study discussed in this press
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issues resulting from the administration of Regeneron's Products
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including serious complications or side effects in connection with
the use of Regeneron's Products and Regeneron's Product Candidates
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ability to continue to develop or commercialize Regeneron's
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limitation Dupixent; ongoing regulatory obligations and oversight
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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
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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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unanticipated expenses; the costs of developing, producing, and
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financial projections or guidance and changes to the assumptions
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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),
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ultimate outcome of any such proceedings and investigations, and
the impact any of the foregoing may have on Regeneron's business,
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complete description of these and other material risks can be found
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ended December 31, 2021. Any forward-looking statements are
made based on management's current beliefs and judgment, and the
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including without limitation any financial projection or guidance,
whether as a result of new information, future events, or
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Sanofi Forward-Looking Statements
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Forward-looking statements are generally identified by the words
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Regeneron
Contacts:
Media
Relations
Ashleigh
Dixon
Tel: +1
914-374-2422
Ashleigh.Dixon@regeneron.com
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Investor
Relations
Vesna
Tosic
Tel: +1
914-847-5443
Vesna.Tosic@regeneron.com
|
|
|
Sanofi
Contacts:
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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
Delépine
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.