TARRYTOWN, N.Y. and
PARIS, May
26, 2020 /PRNewswire/ --
In the pivotal trial, more than twice as many children
achieved clear or almost clear skin and more than four times
achieved itch reduction with Dupixent plus topical corticosteroids
(TCS) compared to TCS alone
Three-quarters of patients receiving Dupixent achieved at
least a 75% improvement in overall disease, with an average
improvement of approximately 80%
Safety consistent with the established safety profile of
Dupixent across adult and adolescent atopic dermatitis
patients
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the U.S. Food and Drug Administration (FDA)
has approved Dupixent® (dupilumab) for children aged 6
to 11 years with moderate-to-severe atopic dermatitis whose disease
is not adequately controlled with topical prescription therapies or
when those therapies are not advisable. Dupixent is the only
biologic medicine approved for this population.
"This approval brings the paradigm-changing efficacy and
established safety profile of Dupixent to children with
moderate-to-severe atopic dermatitis. This young, vulnerable
population struggles with debilitating symptoms and disease
covering over half of their body, impacting them and their families
who spend countless hours helping them manage their disease," said
George D. Yancopoulos, M.D., Ph.D.,
Co-founder, President and Chief Scientific Officer at Regeneron.
"We continue to study Dupixent in even younger children with
uncontrolled moderate-to-severe atopic dermatitis from 6 months to
5 years old, as well as in children with uncontrolled, persistent
asthma. Additionally, we are investigating Dupixent in other
diseases driven by type 2 inflammation including eosinophilic
esophagitis, food and environmental allergies, chronic obstructive
pulmonary disease and other dermatologic diseases."
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins, and is not an immunosuppressant. 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 atopic
dermatitis, asthma and chronic rhinosinusitis with nasal polyposis
(CRSwNP). Across all approved indications globally, more than
150,000 patients have been treated with Dupixent.
"This FDA approval is another milestone in the journey for
Dupixent as an innovative biologic treatment for atopic dermatitis
and other conditions driven in part by type 2 inflammation," said
John Reed, M.D., Ph.D., Global Head
of Research and Development at Sanofi. "Caregivers of children with
moderate-to-severe atopic dermatitis and their physicians now have
access to a first-in-class biologic with a proven safety profile, a
factor that often plays a critical role in treatment decisions for
younger patients. Additionally, improvements in itch and disease
severity were observed as early as two weeks after the first dose
and continued throughout active treatment, which is important for
these children and their families."
The FDA evaluated the Dupixent application under Priority
Review, which is reserved for medicines that represent potentially
significant improvements in efficacy or safety in treating serious
conditions. The FDA previously granted Breakthrough Therapy
designation to Dupixent for the treatment of severe atopic
dermatitis in children 6 months to 11 years of age not well
controlled on topical prescription medications. The Breakthrough
Therapy designation was created to expedite the development and
review of drugs developed for serious or life-threatening
conditions.
Atopic dermatitis, the most common form of eczema, is a chronic
inflammatory disease that often appears as a rash on the skin.
Moderate-to-severe atopic dermatitis is characterized by rashes
that can potentially cover much of the body and can include
intense, persistent itching, skin lesions and skin dryness,
cracking, redness or darkness, crusting and oozing. Itch is one of
the most burdensome symptoms for patients and can be
debilitating.
Dupixent comes in two doses, prescribed based on weight (300 mg
every four weeks for children ≥15 to <30 kg and 200 mg every two
weeks for children ≥30 to <60 kg, following an initial loading
dose) as a pre-filled syringe for pediatric patients aged 6 to 11
years.
The FDA approval is based on data that includes pivotal Phase 3
results on the efficacy and safety of Dupixent combined with
topical corticosteroids (TCS) compared to TCS alone in children
with severe atopic dermatitis. In the trial, children treated with
Dupixent and TCS experienced significant improvements in overall
disease severity, skin clearance and itch.
Results at 16 weeks showed:
- 84% improvement in average EASI (Eczema Area and Severity
Index) score from baseline in patients who received Dupixent every
four weeks and 80% in patients who received Dupixent every two
weeks, compared to 49% and 48% for TCS alone,
respectively.
- 75% of patients who received Dupixent every four weeks and 75%
of patients who received Dupixent every two weeks achieved EASI-75
(Eczema Area and Severity Index-75), compared to 28% and 26% for
TCS alone, respectively.
- 54% of patients who received Dupixent every four weeks and 61%
of patients who received Dupixent every two weeks experienced at
least a 4-point reduction in itch intensity on a 0 to
10-point scale (weekly average of daily Peak Pruritus
Numerical Rating Scale), compared to 12% and 13% for TCS
alone, respectively.
- 30% of patients who received Dupixent every four weeks and 39%
of patients who received Dupixent every two weeks achieved clear or
almost clear skin (Investigator's Global Assessment or IGA),
compared to 13% and 10% for TCS alone, respectively.
The safety profile of Dupixent with TCS was similar to what was
observed in adults and adolescents with atopic dermatitis, and
consistent through 52 weeks. Safety data over the 16-week treatment
period showed:
- Overall rates of adverse events (AEs) were 65% for Dupixent
every four weeks, 61% for Dupixent every two weeks, and 72% and 75%
for TCS alone, respectively.
- AEs that were more commonly observed with Dupixent included
upper respiratory tract infections (15% for Dupixent every four
weeks, 9% for Dupixent every two weeks, and 8% and 12% for TCS
alone, respectively), injection site reactions (10% for Dupixent
every four weeks, 14% for Dupixent every two weeks, and 7% and 5%
for TCS alone, respectively), nasopharyngitis (10% for Dupixent
every four weeks, 3% for Dupixent every two weeks, and 3% and 10%
for TCS alone, respectively), conjunctivitis (7% for Dupixent every
four weeks, 9% for Dupixent every two weeks, and 3% and 5% for TCS
alone, respectively), vomiting (5% for Dupixent every four weeks,
7% for Dupixent every two weeks, and 7% and 7% for TCS alone,
respectively) and fever (5% for Dupixent every four weeks, 2% for
Dupixent every two weeks, and 7% and 0% for TCS alone,
respectively).
Additional prespecified AEs across all weight groups and doses
included skin infections (6% for Dupixent every four weeks, 8% for
Dupixent every two weeks, and 13% for TCS alone), which is
noteworthy because patients with atopic dermatitis have an
increased risk of skin infections. In adult atopic dermatitis
trials, the incidence of serious skin infections was 57% less with
Dupixent compared to the control groups. In addition, in the
pediatric trial (6-11 years of age), herpes viral infections
occurred in 0% of Dupixent patients every four weeks, 2% of
Dupixent patients every two weeks, and 5% for patients on TCS
alone.
Dupixent has been studied in more than 8,000 patients ages 6
years and older across more than 40 clinical trials.
About Dupixent
Dupixent is an injection under
the skin (subcutaneous injection) at different injection sites. In
the pediatric (6-11 years of age) population, Dupixent is given
either every two weeks (200 mg) or four weeks (300 mg), based on
weight, following an initial loading dose. Dupixent is intended for
use under the guidance of a healthcare professional and can be
given in a clinic or at home by self-administration after training
by a healthcare professional. In children younger than 12 years of
age, Dupixent should be administered by a caregiver.
Dupixent is also approved in the U.S. to treat patients aged 12
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.
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.
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.
Dupilumab Development Program
In addition to the
currently approved indications, Regeneron and Sanofi are also
studying dupilumab in a broad range of clinical development
programs for diseases driven by allergic and other type 2
inflammation, including pediatric asthma (6 to 11 years of age,
Phase 3), pediatric atopic dermatitis (6 months to 5 years of age,
Phase 2/3), 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 have not been
evaluated by any regulatory authority. Dupilumab is being jointly
developed by Regeneron and Sanofi under a global collaboration
agreement.
Dupilumab was invented using Regeneron's proprietary
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 is now
being used in efforts to create prophylactic and treatment
medicines for COVID-19.
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.
- 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; and 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 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 include:
- 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, 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 children aged 6 to 11 years with moderate-to-severe
atopic dermatitis; 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 and product candidates; the likelihood,
timing, and scope of possible regulatory approval and commercial
launch of Regeneron's product candidates and new indications for
Regeneron's Products, such as dupilumab for the treatment of
pediatric asthma, pediatric atopic dermatitis, eosinophilic
esophagitis, chronic obstructive pulmonary disease, bullous
pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food
and environmental allergies, and other potential indications (as
well as in combination with REGN3500); unforeseen 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
(such as Dupixent) 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 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 lead to advancement of product candidates
to clinical trials or therapeutic applications; 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 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 March
31, 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:
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Media
Relations
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Investor
Relations
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Hannah
Kwagh
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Mark
Hudson
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Tel: +1 (914)
847-6314
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Tel: +1 (914)
847-3482
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Hannah.Kwagh@regeneron.com
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Mark.Hudson@regeneron.com
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Sanofi
Contacts:
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Media
Relations
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Investor
Relations
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Nicolas
Kressmann
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Felix
Lauscher
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Tel.: +1 (732)
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Tel: +33 (0)1 53 77
45 45
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Nicolas.Kressmann@sanofi.com
|
ir@sanofi.com
|
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SOURCE Regeneron Pharmaceuticals, Inc.