TARRYTOWN, N.Y. and
CAMBRIDGE, Mass., March 11, 2019 /PRNewswire/ --
Only therapy that targets the IL-4/IL-13 pathway, a key
driver of the allergic or type 2 inflammation that underlies atopic
dermatitis
In a Phase 3 trial, Dupixent significantly reduced the extent
and severity of disease and itching, and helped adolescents achieve
clearer skin
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced that the U.S. Food and Drug Administration (FDA)
has approved Dupixent® (dupilumab) for adolescent
patients 12 to 17 years of age with moderate-to-severe atopic
dermatitis whose disease is not adequately controlled with topical
prescription therapies or when those therapies are not advisable.
Dupixent can be used with or without topical corticosteroids.
"For the first time, adolescents with uncontrolled
moderate-to-severe atopic dermatitis have an approved biologic
treatment option to help control persistent, often debilitating
symptoms such as chronic itch and widespread rash. Today's approval
expands the use of Dupixent in the U.S. to include both adults and
adolescents with atopic dermatitis or moderate-to-severe asthma,"
said George D. Yancopoulos, M.D.,
Ph.D., President and Chief Scientific Officer at Regeneron. "Given
that Dupixent targets a key pathway in type 2 inflammation, we are
also investigating it in a broad development program in patients
with other type 2 inflammatory diseases including eosinophilic
esophagitis, chronic rhinosinusitis with nasal polyps, where we
recently announced positive Phase 3 results and Priority Review of
a U.S. regulatory submission, and food and environmental
allergies."
Dupixent is a targeted biologic therapy that inhibits signaling
of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key
proteins that may play a central role in type 2 inflammation that
underlies atopic dermatitis and several other allergic
diseases.
"The approval of Dupixent for adolescents with
moderate-to-severe atopic dermatitis means that for the first time
these patients and their families, who often help them manage this
debilitating disease, will have access to a first-of-its-kind
biologic treatment that has already been used to treat
approximately 50,000 patients in the U.S.," said John Reed, M.D., Ph.D., Head of Research and
Development at Sanofi. "Our Phase 3 data demonstrated that Dupixent
treatment significantly improved skin lesions, reduced itching, and
helped clear the skin of these adolescent patients."
The FDA evaluated the Dupixent application under Priority
Review, which is reserved for medicines that represent potentially
significant improvements in safety or efficacy in treating serious
conditions. Dupixent was also granted Breakthrough Therapy
designation by the FDA for inadequately controlled
moderate-to-severe atopic dermatitis in adolescents. The
Breakthrough Therapy designation was created to expedite the
development and review of drugs developed for serious or
life-threatening conditions.
In the pivotal Phase 3 trial evaluating
Dupixent monotherapy in adolescent patients with uncontrolled
moderate-to-severe atopic dermatitis, the safety and efficacy
were generally consistent with that previously seen in adult
studies. At 16 weeks:
- The average improvement in the Eczema Area and Severity Index
(EASI) from baseline was approximately 66% compared to 24% for
placebo
- More than 10 times as many patients had clear or almost clear
skin with Dupixent compared to placebo: 24% of patients who
received Dupixent achieved clear or almost clear skin compared to
2% with placebo, as measured by an Investigator's Global Assessment
(IGA) score of 0 or 1, the primary endpoint of the trial
- Over five times as many patients saw overall disease
improvement of at least 75% with Dupixent compared to placebo: 42%
of patients who received Dupixent achieved 75% or greater skin
improvement compared to 8% with placebo, as measured by
EASI-75
- Over seven times as many patients experienced significantly
reduced itch with Dupixent compared to placebo: 37% of patients who
received Dupixent achieved a clinically meaningful improvement in
itch of at least four points on the Peak Pruritus Numerical Rating
Scale (NRS) compared to 5% with placebo
Dupixent has been studied in more than 7,000 patients 12 years
and older in over 30 clinical trials. The safety profile of
Dupixent in the adolescent trial was similar to the safety profile
from trials in adults with atopic dermatitis, and consistent
through 52 weeks. The most common adverse events were injection
site reactions, eye and eyelid inflammation including redness,
swelling and itching, pain in the throat (oropharyngeal pain) and
cold sores in the mouth or on the lips.
Atopic dermatitis, a form of eczema, is a chronic inflammatory
disease with symptoms often appearing 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, crusting and oozing. Itch is one of the most
burdensome symptoms for patients and can be debilitating.
About Dupixent
Dupixent comes in two doses (200 mg
and 300 mg), each as a pre-filled syringe. Dupixent is intended for
injection under the skin (subcutaneous injection) and is given
every other week following an initial loading dose. It can be given
in a clinic or, for convenience, at home by self-administration
after training by a healthcare professional.
Dupixent is also approved in the U.S. for the treatment of adult
patients 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; and for use with
other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in people aged 12 years and older whose
asthma is not controlled with their current asthma medicines. In
2016, the FDA granted Breakthrough Therapy designation for
Dupixent for the treatment of moderate-to-severe (adolescents
12 to 17 years of age) and severe (children 6 months to 11 years of
age) atopic dermatitis not well controlled on topical prescription
medications.
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 also approved in a number of
other countries for use in certain adults with moderate-to-severe
atopic dermatitis. Dupixent is currently under regulatory review
for adolescents with moderate-to-severe atopic dermatitis in
several countries, including Japan, and in the European Union (EU).
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 chronic rhinosinusitis with nasal polyps
(Phase 3 completed), pediatric (6 to 11 years of age) atopic
dermatitis (Phase 3), pediatric (6 months to 5 years of age) atopic
dermatitis (Phase 2/3), pediatric (6 to 11 years of age) asthma
(Phase 3), eosinophilic esophagitis (Phase 2/3), and food and
environmental allergies (Phase 2). A future trial is planned for
chronic obstructive pulmonary disease. Dupilumab is also being
studied in combination with REGN3500, which targets IL-33. These
potential uses are investigational and the safety and efficacy have
not been evaluated by any regulatory authority. Dupilumab and
REGN3500 were invented using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully human antibodies, and are being jointly developed by
Regeneron and Sanofi under a global collaboration agreement.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat people 12 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 12
years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe 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.
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 (if you also have atopic dermatitis)
- have a parasitic (helminth) infection
- are taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- 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. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
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. If you have atopic dermatitis, tell your
healthcare provider if you have any new or worsening eye problems,
including eye pain or changes in vision.
- Inflammation in 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 injection site
reactions, pain in the throat (oropharyngeal pain) and cold sores
in your mouth or on your lips. Eye and eyelid inflammation,
including redness, swelling and itching have been seen in patients
who have atopic dermatitis.
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. 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 adolescents 12 years of age and older, it
is recommended that DUPIXENT be administered by or under
supervision of an adult.
Please see accompanying full Prescribing Information
including Patient Information.
About Regeneron Pharmaceuticals, Inc.
Regeneron
(NASDAQ: REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for 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, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and 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 nature, timing, and possible success and therapeutic
applications of Regeneron's products, product candidates, and
research and clinical programs now underway or planned, including
without limitation Dupixent® (dupilumab) Injection; the
likelihood, timing, and scope of possible regulatory approval and
commercial launch of Regeneron's late-stage product candidates and
new indications for marketed products, such as dupilumab for the
treatment of pediatric atopic dermatitis, pediatric asthma, chronic
rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass
allergy, food allergy (including peanut), chronic obstructive
pulmonary disease, and other potential indications (as well as in
combination with REGN3500); unforeseen safety issues resulting from
the administration of products and product candidates (such as
dupilumab) in patients, including serious complications or side
effects in connection with the use of Regeneron's product
candidates in clinical trials; ongoing regulatory obligations and
oversight impacting Regeneron's marketed products (such as
Dupixent), research and clinical programs, and business, including
those relating to patient privacy; 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, including without
limitation dupilumab; the availability and extent of reimbursement
of the Company'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; uncertainty of
market acceptance and commercial success of Regeneron's products
and product candidates (such as Dupixent) and the impact of studies
(whether conducted by Regeneron or others and whether mandated or
voluntary) on the commercial success of any such products and
product candidates; 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 or its collaborators may be
replicated in other studies and lead to 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 to
perform 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 proceedings relating to
EYLEA® (aflibercept) Injection, Dupixent, and
Praluent® (alirocumab) Injection, the ultimate outcome
of any such litigation proceedings, 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, 2018. 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
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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 absence of guarantee that
the product will 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
conditions, as well as those risks 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,
2017. 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: +1 (914)
847-1546
Sharon.Chen@regeneron.com
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Investor
Relations
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Hudson
Tel: +1 (914)
847-3482
Mark.Hudson@regeneron.com
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Sanofi
Contacts:
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Relations
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Koss
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45 45
ir@sanofi.com
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SOURCE Regeneron Pharmaceuticals, Inc.