TARRYTOWN, N.Y. and
PARIS, Oct.
25, 2021 /PRNewswire/ --
Dupixent 300 mg weekly significantly improved the ability to
swallow and reduced eosinophils in the esophagus compared to
placebo, reinforcing positive results from first Phase 3
trial
Eosinophilic esophagitis is a progressive disease that
damages the esophagus and impairs the ability to swallow; 90% of
trial participants had at least one coexisting type 2 inflammatory
condition such as asthma or atopic dermatitis
Dupixent is the only biologic medicine to show positive,
clinically meaningful Phase 3 results in these patients; regulatory
filings planned for 2022
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced results from a second Phase 3 trial assessing the
investigational use of Dupixent® (dupilumab) in patients
12 years and older with eosinophilic esophagitis (EoE). The trial
met its co-primary endpoints in patients taking Dupixent 300 mg
weekly, showing significant improvements in clinical (Dysphagia
Symptom Questionnaire) and histologic disease measures compared to
placebo. In September 2020, the U.S.
Food and Drug Administration (FDA) granted Breakthrough Therapy
designation to Dupixent for the treatment of patients 12 years and
older with EoE.
"This trial gives insight into how terrible this disease can be,
with more than a third of patients having previously required
invasive endoscopic dilations that can temporarily reduce symptoms
but carry the risk of rupturing the esophagus," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer at Regeneron and a principal inventor
of Dupixent. "Dupixent, which blocks the IL-4 and IL-13 pathways,
has now shown compelling results across a spectrum of diseases
where there has been great unmet need. In fact, our positive Phase
3 data in six different diseases help confirm our early hypothesis
that IL-4 and IL-13 are the main drivers of allergic or type 2
inflammation and disease, whether manifested in the
gastrointestinal tract as eosinophilic esophagitis, the respiratory
tract as asthma or nasal polyps, or the skin as atopic dermatitis,
chronic spontaneous urticaria, or prurigo nodularis."
EoE is a chronic and progressive type 2 inflammatory disease
that damages the esophagus and prevents it from working properly.
At times, swallowing the smallest quantity of food or taking a
sip of water can be a painful and worrisome choking experience.
Those with EoE live with anxiety and frustration from having a
constantly evolving list of trigger foods to avoid. Dilation
(physical expansion) of the esophagus, which is used to address
narrowing, is often painful. In severe cases, a feeding tube is the
only option to ensure proper caloric intake and weight gain. People
with EoE may have poor quality of life and are more likely to
experience depression, especially as they age, than people without
EoE. In the U.S. there are approximately 160,000 patients with EoE
who are currently treated, of whom approximately 48,000 have failed
multiple treatments.
"The current standard of care for people with eosinophilic
esophagitis may only provide limited relief of their symptoms.
Efforts to develop a treatment that targets an underlying cause of
the disease has eluded the field for some time, resulting in an
incredible unmet need," said Naimish
Patel, M.D. Head of Global Development, Immunology and
Inflammation at Sanofi. "We are encouraged that Dupixent, which
targets IL-4 and IL-13, was able to reduce inflammation in the
esophagus and provided significant relief when swallowing for
patients taking the weekly dose. We look forward to continuing to
study Dupixent's potential role in addressing the underlying type 2
inflammation that can lead to eosinophilic esophagitis."
In this trial, 80 patients were enrolled into a Dupixent 300 mg
weekly treatment group and 79 patients were enrolled into the
placebo group. The co-primary endpoints at 24 weeks assessed
patient-reported measures of difficulty swallowing (change from
baseline in the Dysphagia Symptom Questionnaire, or DSQ), and
esophageal inflammation (proportion of patients achieving peak
esophageal intraepithelial eosinophil count of ≤6 eos/high power
field [hpf]).
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). Dupixent patients experienced a 23.78 point
improvement on the 0-84 DSQ scale, 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 Dupixent patients achieved histological
disease remission: 59% of patients achieved histological disease
remission compared to 6% of placebo patients (p<0.0001). This
was measured by the proportion of patients who achieved a peak
esophageal intraepithelial eosinophil count of ≤6 eos/hpf; 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, overall rates of adverse
events were 84% (67/80) for Dupixent 300 mg weekly and 71% (55/78)
for placebo. Adverse events that were more commonly (≥5%)
observed with Dupixent every week included injection site reactions
(38% [30/80] Dupixent, 33% [26/78] placebo), fever (6% [5/80]
Dupixent, 1% [1/78] placebo), sinusitis (5% [4/80] Dupixent, 0%
[0/78] placebo), COVID-19 (5% [4/80] Dupixent, 0% [0/78] placebo)
and hypertension (5% [4/80] Dupixent, 1% [1/78] placebo). No
imbalance was observed in rates of treatment discontinuation due to
adverse events between Dupixent (3% [2/80]) and placebo (3% [2/78])
groups prior to week 24.
Detailed results from the trial will be shared at an upcoming
medical meeting. Results from the extended active treatment period
(up to 52 weeks) of a previously reported Phase 3 trial
studying Dupixent 300 mg weekly for 24 weeks were also recently
presented at the United European Gastroenterology Week Virtual
2021 congress. Data from the clinical trial program will be
submitted to regulatory authorities by 2022.
Dupixent was 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 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. The 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 in 2022.
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 300,000
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
60 clinical trials involving more than 10,000 patients with various
chronic diseases driven in part by type 2 inflammation.
Regeneron and Sanofi are studying dupilumab in a broad range of
diseases driven by type 2 inflammation or other allergic processes
including chronic obstructive pulmonary disease with evidence of
type 2 inflammation (Phase 3), pediatric atopic dermatitis (6
months to 5 years of age, 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. Dupilumab is being jointly developed by Regeneron and
Sanofi under a global collaboration agreement.
U.S. Indications
DUPIXENT is
a prescription medicine used:
- to treat people aged 6 years 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 people
aged 6 years 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" if you are treated 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 (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and
tell your healthcare provider or get emergency help right away if
you get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your healthcare provider if you have
any new or worsening eye problems, including eye pain or changes in
vision.
- 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, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects by indication are as
follows:
- Atopic dermatitis: injection site reactions, eye and
eyelid inflammation, including redness, swelling, and itching, 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, 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. Your healthcare provider
will tell you how much DUPIXENT to inject and how often to inject
it. DUPIXENT is an injection given under the skin (subcutaneous
injection). If your healthcare provider decides that you or a
caregiver can give DUPIXENT injections, you or your caregiver
should receive training on the right way to prepare and inject
DUPIXENT. Do not try to inject DUPIXENT until you have been
shown the right way by your healthcare provider. In children 12
years of age and older, it is recommended that DUPIXENT be
administered by or under supervision of an adult. In children
younger than 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
Sanofi is dedicated to supporting
people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100
countries, Sanofi is transforming scientific innovation
into healthcare solutions around the globe.
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 (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
(collectively, "Regeneron's Product Candidates") and research and
clinical programs now underway or planned, including without
limitation Dupixent® (dupilumab); 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 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 release, on any of the foregoing
or any potential regulatory approval of Regeneron's Products (such
as Dupixent) and Regeneron's Product Candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
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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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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
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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 may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
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costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
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agreement, including Regeneron's 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-COVTM (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
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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, 2020 and its
Form 10-Q for the quarterly period ended June 30, 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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including without limitation any financial projection or guidance,
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Regeneron uses its media and investor relations website and
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Regeneron
Contacts:
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Relations
Sharon
Chen
Tel: +1
914-847-1546
Sharon.Chen@regeneron.com
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Relations
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Tosic
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914-847-5443
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Sanofi
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Sanofi Investor
Relations – Contacts Paris
Eva
Schaefer-Jansen
Arnaud
Delepine
Nathalie
Pham
Sanofi Investor
Relations – Contact North America
Felix
Lauscher
Sanofi IR main
line:
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45 45
investor.relations@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.