TARRYTOWN, N.Y. and
PARIS, April 3, 2020 /PRNewswire/ --
Patients who added Dupixent to topical corticosteroids
improved skin clearance; average overall disease improved by
approximately 80% based on mean EASI score
Data further reinforce consistent safety and tolerability
profile observed across adult and adolescent atopic dermatitis
trials, including a numerically lower rate of skin infections
compared to placebo
Expanded Dupixent indication in children aged 6 to 11 years
currently under Priority Review with the FDA; decision expected by
May 26, 2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
today announced detailed positive results from a pivotal Phase 3
trial evaluating Dupixent® (dupilumab) for children aged
6 to 11 years with uncontrolled severe atopic dermatitis. In the
trial, Dupixent combined with standard-of-care topical
corticosteroids (TCS) significantly improved disease signs,
symptoms and health-related quality of life in these children.
Detailed results will be presented during a session at the 2020
Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on
April 5. The companies previously
announced topline positive results of this trial in
August 2019.
"In my practice, I see children with severe atopic dermatitis
struggling with intense, persistent itching and skin lesions
covering much of their body, and caregivers who are desperate for
additional treatment options that can help control this disease,"
said Amy S. Paller, M.D, Walter J.
Hamlin Professor and Chair of Dermatology and Professor of
Pediatrics at Northwestern University
Feinberg School of Medicine, and principal investigator of the
trial. "Data from the Phase 3 trial in children aged 6 to 11 adds
to the established efficacy and safety data in adults and
adolescents, and provides hope to physicians and families for a
potential new treatment option for children with this chronic
disease."
Data to be presented at RAD show that at 16 weeks, nearly three
times as many children achieved clear or almost clear skin when
treated with Dupixent and TCS, and more than two-thirds experienced
at least a 75% overall improvement of their disease compared to TCS
alone. Additionally, more than three times as many children
experienced a significant reduction in itch with Dupixent and TCS,
compared to TCS alone. Itch is often described as the most
burdensome symptom of atopic dermatitis. Improvements in itch and
disease severity were observed with Dupixent as early as two weeks
after the first dose and continued throughout active
treatment.
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 atopic dermatitis, asthma and chronic rhinosinusitis
with nasal polyposis (CRSwNP). Across all approved indications in
the U.S., more than 100,000 patients have started treatment with
Dupixent.
The results from the Phase 3 pediatric trial are currently being
reviewed by regulatory authorities, including in the U.S., EU and
Canada. In the U.S., the
supplemental Biologics License Application for children aged 6 to
11 years is currently under Priority Review, with a target action
date of May 26, 2020. There are
currently no biologic medicines approved for children with severe
atopic dermatitis. In 2016, the U.S. Food and Drug Administration
(FDA) granted Breakthrough Therapy designation to review Dupixent
for the treatment of severe atopic dermatitis in children 6 months
to 11 years of age not well controlled on topical prescription
medications. Dupixent is also being studied in a Phase 3 trial for
children with uncontrolled persistent asthma, with results expected
later this year. The safety and efficacy of Dupixent in these
pediatric populations have not been fully evaluated by any
regulatory authority.
The virtual late-breaking presentation at RAD included the
following data:
The Phase 3, randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent combined with TCS in 367 children with severe atopic
dermatitis that covered on average 60% of their skin. More than 90%
of children in the trial had a history of at least one atopic
comorbidity, including asthma (nearly 50%).
Results at 16 weeks showed:
- 33% of patients who received Dupixent every four weeks (300 mg,
regardless of weight) and 30% of patients who received Dupixent
every two weeks (100 mg or 200 mg, based on weight) achieved clear
or almost clear skin (Investigator's Global Assessment or IGA),
compared to 11% for TCS alone (p<0.0001 and p=0.0004,
respectively), the primary endpoint in the U.S.
- 70% of patients who received Dupixent every four weeks and 67%
of patients who received Dupixent every two weeks achieved EASI-75
(Eczema Area and Severity Index-75), compared to 27% for TCS alone
(p<0.0001 for both), a co-primary endpoint outside of the
U.S.
- The average EASI score improvement from baseline was 82% in
patients who received Dupixent every four weeks and 78% in patients
who received Dupixent every two weeks, compared to 49% for TCS
alone (p<0.0001 for both).
- 60% of patients who received Dupixent every four weeks and 68%
of patients who received Dupixent every two weeks experienced at
least a 3-point reduction in itch intensity on an 11-point scale
(weekly average of daily Peak Pruritus Numerical Rating Scale),
compared to 21% for TCS alone (p<0.0001 for both).
Safety data over the 16-week treatment period showed:
- Overall rates of adverse events were 65% for Dupixent every
four weeks, 67% for Dupixent every two weeks and 73% for TCS
alone.
- Adverse events that were more commonly observed with Dupixent
included conjunctivitis (7% for Dupixent every four weeks, 15% for
Dupixent every two weeks and 4% for placebo), nasopharyngitis (13%
for Dupixent every four weeks, 7% for Dupixent every two weeks and
7% placebo) and injection site reactions (10% for Dupixent every
four weeks, 11% for Dupixent every two weeks and 6% for
placebo).
- Additional prespecified adverse events included skin infections
(6% for Dupixent every four weeks, 8% for Dupixent every two weeks
and 13% for placebo) and herpes viral infections (2% for Dupixent
every four weeks, 3% for Dupixent every two weeks and 5% for
placebo).
Dupilumab Development Program
To date, Dupixent
has been studied in more than 8,000 patients across 40
clinical trials in various chronic diseases driven by type 2
inflammation.
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). Dupilumab is also being
studied in combination with REGN3500 (SAR440340), 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 are
being jointly developed by Regeneron and Sanofi under a global
collaboration agreement.
Dupilumab and REGN3500 were 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
Praluent® (alirocumab), Libtayo®
(cemiplimab-rwlc) 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 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 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 to treat chronic rhinosinusitis with nasal
polyposis 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 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. 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. 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.
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, infectious diseases, pain
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 nature, timing, and possible success and therapeutic
applications of products marketed by Regeneron and/or its
collaborators (collectively, "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 pediatric asthma; 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 Regeneron's Products and
product candidates; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's late-stage
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 and product candidates (such as dupilumab) in
patients, including serious complications or side effects in
connection with the use of Regeneron's Products and product
candidates in clinical trials; ongoing regulatory obligations and
oversight impacting Regeneron's 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 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 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 (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. 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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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
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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, the risk
of global disruption, including pandemics, 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, 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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Relations
Hannah
Kwagh
Tel: +1 (914)
847-6314
Hannah.Kwagh@regeneron.com
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Relations
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847-7786
Justin.Holko@regeneron.com
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Sanofi
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SOURCE Regeneron Pharmaceuticals, Inc.