TARRYTOWN, N.Y. and
PARIS, Aug.
6, 2019 /PRNewswire/ --
U.S. FDA submission for children planned for 4Q 2019
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that a pivotal Phase 3 trial evaluating
Dupixent® (dupilumab) to treat severe atopic dermatitis
in children aged 6 to 11 years met its primary and secondary
endpoints. Dupixent is the first and only biologic to show positive
results in this pediatric atopic dermatitis population. In the
U.S., Dupixent is currently approved in patients 12 years and older
with moderate-to-severe atopic dermatitis, as well as
moderate-to-severe asthma and adults with severe chronic
rhinosinusitis with nasal polyposis (CRSwNP).
The topline data show that for children with severe atopic
dermatitis (covering nearly 60% of their skin surface on average),
adding Dupixent to standard-of-care topical corticosteroids (TCS)
significantly improved measures of overall disease severity, skin
clearing, itching and health-related quality of life, compared to
TCS alone. In addition, the safety data were consistent with the
previously documented safety profile of Dupixent in older
populations, including a numerically lower rate of skin infections
compared to placebo.
"The results from this trial, the first to assess a biologic
medicine in children under 12 with atopic dermatitis, are very
important because of the significant unmet needs in this patient
population. Children in the trial had suffered from severe atopic
dermatitis for most of their lives," said George D. Yancopoulos, M.D., Ph.D., President
and Chief Scientific Officer of Regeneron. "The trial showed that
Dupixent significantly improved outcomes and quality of life,
with no new safety signals."
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 CRSwNP.
"In this trial, children with severe atopic dermatitis had
uncontrolled disease covering, on average, nearly 60% of their
skin. The unrelenting symptoms of this disease, which impact not
just the child but the whole family, include widespread
rashes, intense and persistent itching, and skin
lesions," said John Reed, M.D.,
Ph.D., Global Head of Research and Development at Sanofi. "Symptoms
of severe atopic dermatitis can take a toll on children both
physically and emotionally. We are encouraged by these results,
which demonstrate that Dupixent improved skin lesions,
reduced itching, cleared the skin and importantly, improved
health-related quality of life measures for these young
patients."
The primary endpoints assessed the proportion of patients
achieving an Investigator's Global Assessment (IGA) score of 0
(clear) or 1 (almost clear) and 75% improvement in Eczema Area and
Severity Index (EASI-75, the co-primary endpoint outside of the
U.S.) at 16 weeks.
Results at 16 weeks included:
- 70% of patients who received Dupixent every four weeks (300 mg
flat dose) and 67% of patients who received Dupixent every two
weeks (100 mg or 200 mg, based on weight) achieved 75% or greater
skin improvement (EASI-75), compared to 27% for placebo
(p<0.0001 for both).
- 33% of patients who received Dupixent every four weeks and 30%
of patients who received Dupixent every two weeks achieved clear or
almost clear skin (IGA; score of 0 or 1), compared to 11% for
placebo (p<0.0001 and p=0.0004, respectively).
- The average EASI score improvement from baseline was 82% in the
Dupixent every four weeks group and 78% in the Dupixent every two
weeks group, compared to 49% for placebo (p<0.0001 for
both).
- Dupixent demonstrated significant itch relief, and also
improved measures of patient-reported outcomes, such as anxiety,
depression and health-related quality of life of parents and family
members.
For the 16-week treatment period, the overall rates of adverse
events were 65% for Dupixent every four weeks, 67% for Dupixent
every two weeks and 73% for placebo. 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).
Detailed results from this trial will be presented at a future
medical meeting and data will be submitted to regulatory
authorities, starting with the U.S. Food and Drug Administration
(FDA) in 4Q 2019. In 2016, the FDA granted Breakthrough Therapy
designation for Dupixent for the treatment of moderate-to-severe
(12 to 17 years of age) and severe (6 months to 11 years of age)
atopic dermatitis. The efficacy and safety of Dupixent in children
below the age of 12 has not been reviewed by any regulatory
authority.
About the Dupixent Pediatric Trial
The Phase 3,
randomized, double-blind, placebo-controlled trial evaluated the
efficacy and safety of Dupixent combined with TCS in children with
severe atopic dermatitis. The trial enrolled 367 patients aged 6 to
11 years with severe atopic dermatitis whose disease could not be
adequately controlled with topical medications. In total, 92% of
these patients suffered from at least one concurrent condition such
as allergic rhinitis, asthma and food allergy.
All patients received TCS throughout the trial. Patients were
randomized into one of three treatment groups for the 16-week
treatment period: Dupixent subcutaneous injection 300 mg every four
weeks (with an initial dose of 600 mg); Dupixent 100 mg or 200 mg
every two weeks, based on weight (100 mg for <30 kg, 200 mg for
³30 kg), with an initial dose of 200 mg or 400 mg, respectively;
and placebo every two or four weeks.
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 and atopic dermatitis (6
to 11 years of age, Phase 3), pediatric atopic dermatitis (6 months
to 5 years of age, Phase 2/3), eosinophilic esophagitis (Phase
2/3), chronic obstructive pulmonary disease (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 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.
- 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 accompanying full Prescribing Information
including Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for 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
disease, 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 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 asthma
and pediatric atopic dermatitis, eosinophilic esophagitis, chronic
obstructive pulmonary disease, food and environmental allergies,
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 (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) Injection, the ultimate outcome of any such
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. 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 and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to
future financial results, events, operations, services, product
development and potential, and statements regarding future
performance. 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, the uncertainties inherent in research and
development, future clinical data and analysis, including post
marketing, decisions by regulatory authorities, such as the FDA or
the EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the absence of guarantee that the
product candidates if approved will be commercially successful, the
future approval and commercial success of therapeutic alternatives,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic
conditions, the impact of cost containment initiatives and
subsequent changes thereto, the average number of shares
outstanding as well as those 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, 2018.
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
|
Investor
Relations
|
Sharon
Chen
|
Justin
Holko
|
Tel: +1 (914)
847-5018
|
Tel: +1 (914)
847-7786
|
Sharon.Chen@regeneron.com
|
Justin.Holko@regeneron.com
|
|
Sanofi Contacts:
|
|
Media
Relations
|
Investor
Relations
|
Ashleigh
Koss
|
George
Grofik
|
Tel: +1 (908)
981-8745
|
Tel: +33 (0)1 53 77
45 45
|
Ashleigh.Koss@sanofi.com
|
ir@sanofi.com
|
View original
content:http://www.prnewswire.com/news-releases/dupixent-dupilumab-showed-positive-topline-results-in-phase-3-trial-of-children-aged-6-to-11-years-with-severe-atopic-dermatitis-300896733.html
SOURCE Regeneron Pharmaceuticals, Inc.