TARRYTOWN, N.Y. and
PARIS, Sept. 8, 2020 /PRNewswire/ --
With more than 2,200 patients enrolled, Phase 3 open-label
extension trial is the largest of a biologic medicine ever
conducted in asthma
Data up to three years to be presented at the 2020 ERS
International Congress also show a safety profile consistent with
pivotal asthma trials
Dupixent is the only biologic to demonstrate sustained
improvements in lung function and asthma exacerbations across a
broad patient population with type 2 inflammation
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced new results from a Dupixent® (dupilumab) Phase
3 open-label extension trial that showed the safety and efficacy
profile observed in previous Dupixent trials was maintained for up
to three years in adults and adolescents with moderate-to-severe
asthma. Data from the trial will be presented during a live session
at the virtual 2020 European Respiratory Society (ERS)
International Congress.
"These data suggest Dupixent may slow the progressive
decline in lung function that many patients with moderate-to-severe
asthma experience, as shown by the sustained improvement in lung
function for up to three years. Further, patients on Dupixent
maintained asthma control and reduced rates of severe asthma
attacks that may result in hospitalizations," said Michael Wechsler, M.D., M.M.Sc., Director of the
National Jewish Cohen Family Asthma Institute in Denver, Colorado, and principal investigator
of the trial. "This reinforces the importance of Dupixent as a
continuous, long-term treatment option to improve patients' ability
to breathe and maintain control of their asthma, particularly in
those with higher markers of underlying type 2 inflammation."
The analyses to be presented at ERS included more than 2,200
patients who previously participated in Dupixent asthma trials,
including three pivotal trials that lasted between 24 and 52 weeks.
Patients entered the extension trial after finishing active
treatment or placebo in the initial trials and were treated for up
to an additional two years, providing up to three years of
treatment data in total. The safety analyses included patients from
all three pivotal asthma trials, and the efficacy and biomarker
analyses included patients who were not dependent on oral
corticosteroids (OCS) from the pivotal Phase 2b and Phase 3 QUEST trials. Additional long-term
efficacy data in OCS-dependent patients will be presented at a
later congress. Results showed:
Efficacy:
- Lung function: Patients continued to experience
improvement in lung function by 13-22% at 96 weeks, as measured by
the average change in forced expiratory volume over one second
(FEV1) compared to baseline for the initial asthma
trials.
- Asthma attacks: Patients maintained a low rate of severe
asthma attacks (unadjusted annualized severe exacerbation rate)
with an average of 0.31-0.35 events per year. In the year prior to
commencing Dupixent trials, the rate of severe asthma attacks was
2.09-2.17 events per year.
- Type 2 inflammation: Improvements in lung function and
asthma attacks were greater in those with elevated baseline blood
eosinophils or fractional exhaled nitric oxide (FeNO), which are
markers of type 2 inflammation. In these long-term results,
patients showed reductions in blood eosinophils (23-35%) and in
blood IgE for patients from the pivotal Phase 2b trial (82%) compared to baseline for the
initial asthma trials.
Safety:
- The proportion of patients with adverse events (AEs) in the
open label extension trial was similar to that seen in prior
pivotal trials of Dupixent in asthma. Over the 96-week treatment
period, overall AE rates were 76-88%, and the most common AEs were
nasopharyngitis (18-26%) and injection-site erythema (2-23%).
Overall serious AEs were experienced by 9-13% of patients.
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 asthma, chronic rhinosinusitis with nasal polyposis
(CRSwNP) and atopic dermatitis. Across all approved indications
globally, more than 170,000 patients have been treated with
Dupixent.
About the LIBERTY ASTHMA TRAVERSE OLE Trial
The Phase
3, multicenter, open-label extension trial evaluated long-term
safety and efficacy of Dupixent treatment in 2,282 adults and
adolescents with moderate-to-severe asthma who had previously
participated in a controlled Dupixent clinical trial, including the
pivotal Phase 2b DRI (24 weeks) and
Phase 3 QUEST (52 weeks) trials in patients with moderate-to-severe
asthma and the Phase 3 VENTURE (24 weeks) trial in patients
with severe OCS-dependent asthma. Patients in the open-label
extension trial received 300 mg Dupixent every other week for up to
96 weeks in addition to standard-of-care maintenance therapies. The
primary endpoints were the number and proportion of patients
experiencing any AEs at up to 96 weeks. Secondary endpoints
included mean change in FEV1 and annualized severe
exacerbation rate. Type 2 inflammation was defined as FeNO
(≥25 ppb) or blood eosinophils (≥150 cells/μL) at initial trial
baseline. Data at ERS are presented as a range of mean values
for those treated with placebo and Dupixent in each of the initial
pivotal trials.
About Dupixent
Dupixent is approved in
the U.S. 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. In the EU,
Dupixent is approved for adults and adolescents 12 years and older
as an add-on maintenance treatment for severe asthma with type 2
inflammation characterized by raised blood eosinophils and/or
raised FeNO, who are inadequately controlled with high dose inhaled
corticosteroid (ICS) plus another medicinal product for maintenance
treatment. Dupixent is also approved for use in certain patients
with asthma in Japan and other
countries around the world.
Dupixent is approved for additional uses in certain patients
with atopic dermatitis and CRSwNP in the U.S., EU and Japan, as well as other countries around the
world. 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.
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
medicine for COVID-19.
Dupilumab Development Program
To date, dupilumab has
been studied in more than 10,000 patients across 50 clinical trials
in various chronic diseases driven in part 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 (6-11 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 their 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.
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 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, and 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); 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
Products (such as Dupixent) 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;
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 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, 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
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)), 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
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
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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
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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
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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, 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
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discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under "Risk Factors" and
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Regeneron
Contacts:
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Media
Relations
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Investor
Relations
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Sharon
Chen
|
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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Sally
Bain
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Felix
Lauscher
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Tel.: +1 (781) 264
1097
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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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SOURCE Regeneron Pharmaceuticals, Inc.