TARRYTOWN, N.Y. and
PARIS, Oct.
13, 2020 /PRNewswire/ --
Data in children aged 6-11 further suggest Dupixent has
potential to be best-in-class treatment option
Dupixent significantly reduced severe asthma attacks by up to
65% over one year compared to placebo
Significant and rapid improvement in lung function seen
within two weeks and sustained for up to 52 weeks
U.S. and EU regulatory submissions for children aged 6-11
years planned by Q1 2021
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that a pivotal Phase 3 trial of Dupixent®
(dupilumab) met its primary and all key secondary endpoints in
children aged 6 to 11 years with uncontrolled moderate-to-severe
asthma.
In a broad type 2 inflammatory asthma patient population,
defined as having elevated eosinophils (EOS) or elevated fractional
exhaled nitric oxide (FeNO), Dupixent added to standard of care
significantly reduced asthma attacks (exacerbations) and improved
lung function as early as two weeks after the first dose, compared
to standard of care alone. More than 90% of children in the trial
had at least one concurrent type 2 inflammatory condition including
atopic dermatitis and eosinophilic esophagitis. Safety results from
the trial were generally consistent with the known safety
profile of Dupixent in patients aged 12 years and older with
moderate-to-severe asthma.
"Children with moderate-to-severe asthma live with a heavy and
unpredictable disease burden. Even while taking maximum treatments
including inhaled corticosteroids, they suffer from multiple asthma
attacks each year that may require hospitalization," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer of Regeneron. "These
impressive Phase 3 data in children with asthma show Dupixent
significantly reduced annual severe asthma attacks and also
improved lung function consistently across patients with markers of
type 2 inflammation."
Despite standard-of-care therapy such as inhaled corticosteroids
(ICS), children with uncontrolled moderate-to-severe asthma
continue to experience symptoms such as coughing, wheezing and
difficulty breathing, and are at risk of severe asthma attacks. For
these children, this often leads to frequent hospitalizations and
emergency room visits requiring use of systemic corticosteroids
which can carry significant risks when used long term.
Uncontrolled asthma can cause children to miss school, and
can interfere with physical activity and routine tasks such as
walking up stairs and playing sports. In the U.S., there are
approximately 75,000 children 6-11 years old with uncontrolled
moderate-to-severe asthma, and many more of these children
worldwide.
"Children with uncontrolled moderate-to-severe asthma often
struggle to breathe, largely because of their impaired lung
function, and this can have a serious impact on a child's quality
of life. It not only reduces their ability to participate in
day-to-day activities, but can also take a huge emotional toll on
the child and their family," said John
Reed, M.D., Ph.D., Global Head of Research and Development
at Sanofi. "Dupixent is the only biologic shown in a controlled
Phase 3 trial to improve lung function in children, which is
generally consistent with results seen in the adolescent and adult
trials. These positive data are especially encouraging for younger
children who are struggling to manage their uncontrolled
asthma."
The primary endpoint assessed the annualized rate of severe
asthma attacks in two primary pre-specified populations: patients
with baseline blood EOS ≥300 cells/μl and patients with markers of
type 2 inflammation (FeNO ≥20 ppb or EOS ≥150 cells/μl). Across
these two patient groups respectively, those who added Dupixent
(100 mg or 200 mg every two weeks, based on weight) to standard of
care experienced:
- Reduced rate of severe asthma attacks, with a 65% (p<0.0001)
and 59% (p<0.0001) average reduction over one year compared to
placebo (0.24 and 0.31 events per year for Dupixent vs. 0.67 and
0.75 for placebo, respectively).
- Improved lung function at 12 weeks compared to baseline by
10.15 and 10.53 percentage points for Dupixent vs. 4.83 and 5.32
percentage points for placebo (least squares mean difference for
Dupixent vs. placebo of 5.3 and 5.2 percentage points, p=0.0036 and
p=0.0009), respectively, as measured by percent predicted
FEV1 (FEV1pp). This is a common endpoint in
pediatric asthma trials to evaluate a patient's change in lung
function compared to their predicted lung function based on a
number of factors including age, height and sex, to account for
children's growing lung capacity at different stages of
development. This clinically meaningful improvement in lung
function was observed as early as two weeks and was sustained for
up to 52 weeks.
The safety results from the trial were generally consistent with
the known safety profile of Dupixent in patients aged 12 years and
older with moderate-to-severe asthma. Over one
year, overall rates of adverse events were 83% for Dupixent
and 80% for placebo. Adverse events that were most commonly
observed with Dupixent versus placebo included injection site
reactions (18% Dupixent, 13% placebo), viral upper respiratory
tract infections (12% Dupixent, 10% placebo), and eosinophilia (6%
Dupixent, 1% placebo).
Dupixent is a fully-human monoclonal antibody that inhibits the
signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13)
proteins, that was invented using Regeneron's proprietary
VelocImmune® technology. Data from Dupixent
clinical trials have shown that IL-4 and IL-13 are key drivers of
the type 2 inflammation that plays a major role in asthma, chronic
rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and
eosinophilic esophagitis.
About the LIBERTY ASTHMA VOYAGE Trial
The Phase 3,
randomized, double-blind, placebo-controlled trial evaluated the
efficacy and safety of Dupixent in addition to standard-of-care
maintenance therapy of medium-dose inhaled corticosteroid (ICS)
with a second controller medication or high-dose ICS with or
without a second controller medication. The trial enrolled 408
children aged 6 to <12 years old with uncontrolled
moderate-to-severe asthma. Primary analyses were based on 259
patients with baseline EOS ≥300 cells/µl and 350 patients with
markers of type 2 inflammation (baseline EOS ≥150 cells/μl or FeNO
≥20 ppb). There was no minimum biomarker requirement for
enrollment.
During the 52-week treatment period, patients received
subcutaneous injections of Dupixent 100 mg or 200 mg every two
weeks, based on weight (100 mg for ≤30 kg, 200 mg for >30 kg),
or placebo every two weeks.
About Dupixent
Dupixent is approved in
the U.S. to treat patients aged 6 years and older with
moderate-to-severe atopic dermatitis that is not well controlled
with prescription therapies used on the skin (topical), or who
cannot use topical therapies; for use with other asthma medicines
for the maintenance treatment of moderate-to-severe eosinophilic or
oral steroid dependent asthma in patients aged 12 years and older
whose asthma is not controlled with their current asthma medicines;
and for use with other medicines for the maintenance treatment of
CRSwNP in adults whose disease is not controlled. In adolescents 12
years of age or older, it is recommended that Dupixent be
administered by or under the supervision of an adult. In children
younger than 12 years of age, Dupixent should be administered by a
caregiver.
Outside of the U.S., Dupixent is approved for specific patients
with moderate-to-severe atopic dermatitis and certain patients with
asthma in a number of other countries around the world, including
the EU and Japan. Dupixent is also
approved in the EU and Japan to
treat certain adults with severe CRSwNP.
Across all approved indications globally, more than 170,000
patients have been treated with Dupixent.
Dupixent was invented using Regeneron's
VelocImmune® technology that utilizes a
proprietary genetically-engineered mouse platform endowed with a
genetically-humanized immune system to produce optimized
fully-human antibodies. VelocImmune technology has been
used to create multiple antibodies including Libtayo®
(cemiplimab-rwlc), Praluent® (alirocumab) and
Kevzara® (sarilumab), which are approved in multiple
countries around the world. Regeneron previously used these
technologies to rapidly develop a treatment for Ebola virus
infection, which is currently under review by the FDA, and to
create REGN-COV2, a potentially preventative and therapeutic
investigational medicine for COVID-19 that has been recently
submitted to the FDA for an emergency use authorization (EUA).
Dupilumab Development Program
To date, dupilumab has
been studied in more than 10,000 patients across 50 clinical trials
in various chronic diseases driven by type 2 inflammation. In
addition to the currently approved indications, Regeneron and
Sanofi are studying dupilumab in a broad range of diseases driven
by type 2 inflammation or other allergic processes, including
pediatric asthma (6 to 11 years of age, Phase 3), pediatric
atopic dermatitis (6 months to 5 years of age, Phase 3),
eosinophilic esophagitis (Phase 3), chronic obstructive pulmonary
disease (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis
(Phase 3), chronic spontaneous urticaria (Phase 3), and food and
environmental allergies (Phase 2). These potential uses are
investigational, and the safety and efficacy of dupilumab in these
conditions have not been evaluated by any regulatory authority.
Dupilumab is being jointly developed by Regeneron and Sanofi under
a global collaboration agreement.
U.S. Indications
DUPIXENT is
a prescription medicine used:
- to treat people aged 6 years and older with moderate-to-severe
atopic dermatitis (eczema) that is not well controlled with
prescription therapies used on the skin (topical), or who cannot
use topical therapies. DUPIXENT can be used with or without topical
corticosteroids. It is not known if DUPIXENT is safe and effective
in children with atopic dermatitis under 6 years of age.
- with other asthma medicines for the maintenance treatment
of moderate-to-severe eosinophilic or oral steroid dependent asthma
in people aged 12 years and older whose asthma is not controlled
with their current asthma medicines. DUPIXENT helps prevent severe
asthma attacks (exacerbations) and can improve your breathing.
DUPIXENT may also help reduce the amount of oral corticosteroids
you need while preventing severe asthma attacks and improving your
breathing. DUPIXENT is not used to treat sudden breathing problems.
It is not known if DUPIXENT is safe and effective in children with
asthma under 12 years of age.
- with other medicines for the maintenance treatment of chronic
rhinosinusitis with nasal polyposis (CRSwNP) in adults whose
disease is not controlled. It is not known if DUPIXENT is safe and
effective in children with chronic rhinosinusitis with nasal
polyposis under 18 years of age.
IMPORTANT SAFETY INFORMATION FOR U.S.
PATIENTS
Do not use if
you are allergic to dupilumab or to any of
the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems
- have a parasitic (helminth) infection
- are
scheduled to receive any vaccinations. You should
not receive a "live vaccine" if you
are treated with DUPIXENT.
- are
pregnant or plan to become pregnant.
It is not known
whether DUPIXENT will harm your unborn
baby.
-
- There is a pregnancy exposure registry for women who take
DUPIXENT during pregnancy to collect information about the health
of you and your baby. Your healthcare provider can enroll you or
you may enroll yourself. To get more information about the registry
call 1–877-311-8972 or go to
https://mothertobaby.org/ongoing-study/dupixent/.
- are breastfeeding or
plan to breastfeed. It
is not known whether DUPIXENT passes
into your breast milk.
Tell your healthcare provider about all
the medicines you take, including prescription and over-the-counter medicines, vitamins
and herbal supplements.
Especially tell your healthcare provider if you are taking oral,
topical, or inhaled corticosteroid medicines; have asthma and use
an asthma medicine; or have atopic dermatitis or CRSwNP, and also
have asthma. Do not change or stop your corticosteroid
medicine or other asthma medicine without talking to your
healthcare provider. This may cause other symptoms that were
controlled by the corticosteroid medicine or other asthma medicine
to come back.
DUPIXENT can cause serious side effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and
tell your healthcare provider or get emergency help right away if
you get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. Tell your
healthcare provider if you have any new or
worsening eye problems,
including eye pain or
changes in vision.
-
Inflammation of your blood vessels. Rarely,
this can happen in people with asthma who receive DUPIXENT. This
may happen in people who also take a steroid medicine by mouth that
is being stopped or the dose is being lowered. It is not known
whether this is caused by DUPIXENT. Tell your healthcare provider
right away if you have: rash, shortness of breath, persistent
fever, chest pain, or a feeling of pins and needles or numbness of
your arms or legs.
The most common side effects by
indications are as follows:
- Atopic dermatitis: injection site reactions, eye
and eyelid inflammation, including redness, swelling, and itching,
and cold sores in your mouth or on your lips.
- Asthma: injection site reactions,
pain in the throat (oropharyngeal pain), and
high count of a certain
white blood cell (eosinophilia).
-
Chronic rhinosinusitis with nasal polyposis: injection site reactions,
eye and eyelid inflammation,
including redness, swelling, and itching,
high count of a
certain white blood cell (eosinophilia),
trouble sleeping (insomnia), toothache, gastritis,
and joint pain (arthralgia).
Tell your healthcare provider if
you have any side
effect that bothers you or that does not go away.
These are not all the possible
side effects of DUPIXENT.
Call your doctor for medical
advice about side
effects. You are encouraged to report negative side effects of
prescription drugs to the
FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. Your healthcare provider
will tell you how much DUPIXENT to inject and how often to inject
it. DUPIXENT is an injection given under the skin (subcutaneous
injection). If your healthcare provider decides that you or a
caregiver can give DUPIXENT injections, you or your caregiver
should receive training on the right way to prepare and inject
DUPIXENT. Do not try to inject DUPIXENT until you have been shown
the right way by your healthcare provider. In children 12 years of
age and older, it is recommended that DUPIXENT be administered by
or under supervision of an adult. In children younger than 12 years
of age, DUPIXENT should be given by a caregiver.
Please see full Prescribing Information including
Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that
invents life-transforming medicines for people with serious
diseases. Founded and led for over 30 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to seven
FDA-approved treatments and numerous product candidates in
development, all of which were homegrown in our laboratories. Our
medicines and pipeline are designed to help patients with eye
diseases, allergic and inflammatory diseases, cancer,
cardiovascular and metabolic diseases, pain, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune®, which uses unique
genetically-humanized mice to produce optimized fully-human
antibodies and bispecific antibodies, and through ambitious
research initiatives such as the Regeneron Genetics Center, which
is conducting one of the largest genetics sequencing efforts in the
world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting
people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100
countries, Sanofi is transforming scientific innovation
into healthcare solutions around the globe.
Sanofi, Empowering Life
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such as
"anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
intended to identify such forward-looking statements, although not
all forward-looking statements contain these identifying
words. These statements concern, and these risks and
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virus that has caused the COVID-19 pandemic) on Regeneron's
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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) in children aged 6 to 11 years with uncontrolled
moderate-to-severe asthma; 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), including the study discussed
in this press release, on the commercial success of Regeneron's
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timing, and scope of possible regulatory approval and commercial
launch of Regeneron's product candidates and new indications for
Regeneron's Products, such as Dupixent 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;
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
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payer healthcare and insurance programs, health maintenance
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reimbursement determinations by such payers and new policies and
procedures adopted by such payers; competing drugs and product
candidates that may be superior to, or more cost effective than,
Regeneron's Products and product candidates; the extent to which
the results from the research and development programs conducted by
Regeneron and/or its collaborators may be replicated in other
studies and/or lead to advancement of product candidates to
clinical trials, therapeutic applications, or regulatory approval;
the ability of Regeneron to manufacture and manage supply chains
for multiple products and product candidates; the ability of
Regeneron's collaborators, suppliers, or other third parties (as
applicable) to perform manufacturing, filling, finishing,
packaging, labeling, distribution, and other steps related to
Regeneron's Products and product candidates; unanticipated
expenses; the costs of developing, producing, and selling products;
the ability of Regeneron to meet any of its financial projections
or guidance and changes to the assumptions underlying those
projections or guidance; the potential for any license or
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Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their
respective affiliated companies, as applicable), to be cancelled or
terminated; and risks associated with intellectual property of
other parties and pending or future litigation relating thereto
(including without limitation the patent litigation and other
related proceedings relating to EYLEA® (aflibercept)
Injection, Dupixent, and Praluent® (alirocumab)),
other litigation and other proceedings and government
investigations relating to the Company and/or its operations, the
ultimate outcome of any such proceedings and investigations, and
the impact any of the foregoing may have on Regeneron's business,
prospects, operating results, and financial condition. A more
complete description of these and other material risks can be found
in Regeneron's filings with the U.S. Securities and Exchange
Commission, including its Form 10-K for the year ended December 31, 2019 and its Form 10-Q for the
quarterly period ended June 30,
2020. Any forward-looking statements are made based on
management's current beliefs and judgment, and the reader is
cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to update
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Sanofi Forward-Looking Statements
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Regeneron
Contacts:
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|
Media
Relations
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Investor
Relations
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Sharon
Chen
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Mark
Hudson
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Tel: + (914)
847-1546
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Tel: +1 (914)
847-3482
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Sharon.Chen@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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Bain
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Felix
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Tel.: +33 (0)1 53 77
45 45
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Sally.Bain@sanofi.com
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ir@sanofi.com
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