TARRYTOWN, N.Y. and
PARIS, Sept. 14, 2020 /PRNewswire/ --
Designation based on positive results from Part A of pivotal
Phase 3 trial
Dupixent is the first and only biologic to show positive and
clinically-meaningful Phase 3 results in patients 12 years and
older with eosinophilic esophagitis (EoE)
There are currently no FDA-approved treatments for this
chronic type 2 inflammatory disease that damages the esophagus and
impacts the ability to swallow and eat
Designation supports Dupixent's potential in another disease
driven by type 2 inflammation
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced the U.S. Food and Drug Administration (FDA) has granted
Breakthrough Therapy designation to Dupixent®
(dupilumab) for the treatment of patients 12 years and
older with eosinophilic esophagitis (EoE). The designation for
this investigational use is based on positive results from Part A
of a Phase 3 trial in patients with EoE.
There are currently no FDA-approved medicines for EoE, a chronic
and progressive type 2 inflammatory disease that damages the
esophagus and prevents it from working properly. Over time,
excessive type 2 inflammation causes scarring and narrowing of the
esophagus, making it difficult to swallow. If left untreated, EoE
can affect a patient's ability to eat and cause food to become
stuck after being swallowed (food impaction), which can lead to a
medical emergency. In the U.S. alone, there are approximately
160,000 patients with EoE who are currently being treated with
various unapproved therapies or diet modification. Of these
patients, approximately 50,000 have failed multiple treatments.
Regeneron and Sanofi previously reported positive results from
Part A of the pivotal Phase 3 trial evaluating Dupixent in patients
12 years and older with EoE. Part A of the randomized,
double-blind, placebo-controlled trial of 81 patients met both of
its co-primary endpoints, as well as all key secondary endpoints.
Patients treated weekly with Dupixent 300 mg over a 24-week
treatment period experienced a reduction in symptoms, esophageal
inflammation and abnormal endoscopic findings in the esophagus. The
trial demonstrated safety results consistent with the known safety
profile of Dupixent in its approved indications. The EoE trial is
ongoing, with additional patients enrolling in Part B as well as
patients continuing in a 28-week extended active treatment period
(Part C) after completing either Part A or Part B.
Breakthrough Therapy designation is designed to expedite the
development and review of drugs in the U.S. that target serious or
life-threatening conditions. Drugs qualifying for this designation
must show preliminary clinical evidence that it may demonstrate a
substantial improvement on clinically significant endpoints over
available therapies, or over placebo if there are no available
therapies. In 2017, Dupixent also was granted Orphan Drug
Designation for the potential treatment of EoE. This is given to
investigational medicines intended for the treatment of rare
diseases that affect fewer than 200,000 people in the U.S.
The potential use of Dupixent in eosinophilic esophagitis is
currently under clinical development, and its safety and efficacy
for this indication have not been evaluated by any regulatory
authority.
About Dupixent
Dupixent is approved in
the U.S. to treat patients aged 6 years and older with
moderate-to-severe atopic dermatitis that is not well controlled
with prescription therapies used on the skin (topical), or who
cannot use topical therapies; for use with other asthma medicines
for the maintenance treatment of moderate-to-severe eosinophilic or
oral steroid dependent asthma in patients aged 12 years and older
whose asthma is not controlled with their current asthma medicines;
and for use with other medicines for the maintenance treatment of
CRSwNP in adults whose disease is not controlled. In adolescents 12
years of age or older, it is recommended that Dupixent be
administered by or under the supervision of an adult. In children
younger than 12 years of age, Dupixent should be administered by a
caregiver.
Outside of the U.S., Dupixent is approved for specific patients
with moderate-to-severe atopic dermatitis and certain patients with
asthma in a number of other countries around the world, including
the EU and Japan. Dupixent is also
approved in the EU and Japan to
treat certain adults with severe CRSwNP.
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins. Data from Dupixent clinical trials have shown that IL-4
and IL-13 are key drivers of the type 2 inflammation that plays a
major role in asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP) and atopic dermatitis.
Dupixent was invented using Regeneron's
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been
used to create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Ebola virus
infection, which is currently under review by the FDA, and to
create REGN-COV2, a potentially preventative and therapeutic
medicine for COVID-19.
Dupilumab Development Program
To date, dupilumab has
been studied in more than 10,000 patients across 50 clinical trials
in various chronic diseases driven 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 asthma (6 to 11 years of age, Phase 3), pediatric atopic
dermatitis (6 months to 5 years of age, Phase 3), eosinophilic
esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase
3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3),
chronic spontaneous urticaria (Phase 3), and food and environmental
allergies (Phase 2). These potential uses are investigational, and
the safety and efficacy of dupilumab in these conditions have not
been 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 12 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 12 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.
-
- There is a pregnancy exposure registry for women who take
DUPIXENT during pregnancy to collect information about the health
of you and your baby. Your healthcare provider can enroll you or
you may enroll yourself. To get more information about the registry
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), and
high count of a certain
white blood cell (eosinophilia).
-
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 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 seven
FDA-approved treatments and numerous product candidates in
development, 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, 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.
Sanofi, Empowering Life
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 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 Regeneron's
product candidates and research and clinical programs now underway
or planned, including without limitation Dupixent®
(dupilumab) for the treatment of patients 12 years and older with
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 dupilumab for the treatment of
eosinophilic esophagitis, pediatric asthma, pediatric atopic
dermatitis, chronic obstructive pulmonary disease, bullous
pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food
and environmental allergies, and other potential indications; the
impact (if any) of the Breakthrough Therapy designation status
granted to Dupixent for the treatment of patients 12 years
and older with eosinophilic esophagitis by the U.S.
Food and Drug Administration (the "FDA") on whether Dupixent will
receive FDA approval in this indication and the timing of such
potential approval; uncertainty of market acceptance and
commercial success of Regeneron's Products and product candidates
and the impact of studies (whether conducted by Regeneron or others
and whether mandated or voluntary) on the commercial success of
Regeneron's Products (such as Dupixent) and product candidates;
safety issues resulting from the administration of Regeneron's
Products (such as Dupixent) and product candidates in patients,
including serious complications or side effects in connection with
the use of Regeneron's Products and 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 product candidates; 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 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 applications, or regulatory approval;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's Products and product candidates; unanticipated
expenses; the 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 guidance; the potential for any license or
collaboration 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 without any further product success; 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, and
Praluent® (alirocumab)), 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, 2019 and its Form 10-Q
for the quarterly period ended June
30, 2020. 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 made by
Regeneron. Regeneron does not undertake any obligation to update
publicly 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
social media outlets to publish important information about the
Company, including information that may be deemed material to
investors. Financial and other information about Regeneron is
routinely posted and is accessible on Regeneron's media and
investor relations website (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
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, and the
impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under "Risk Factors" and
"Cautionary Statement Regarding Forward-Looking Statements" in
Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Regeneron
Contacts:
Media
Relations
Sharon
Chen
Tel: + (914)
847-1546
Sharon.Chen@regeneron.com
|
Investor
Relations
Mark
Hudson
Tel: +1 (914)
847-3482
Mark.Hudson@regeneron.com
|
Sanofi
Contacts:
Media
Relations
Sally
Bain
Tel.: +1 (781) 264
1091
Sally.Bain@sanofi.com
|
Investor
Relations
Felix
Lauscher
Tel: +33 (0)1 53 77
45 45
ir@sanofi.com
|
View original
content:http://www.prnewswire.com/news-releases/fda-grants-dupixent-dupilumab-breakthrough-therapy-designation-for-eosinophilic-esophagitis-301129713.html
SOURCE Regeneron Pharmaceuticals, Inc.