TARRYTOWN, N.Y. and
PARIS, May
7, 2019 /PRNewswire/ --
Only biologic approved in the EU for severe asthma with type
2 inflammation, as characterized by raised blood eosinophils and/or
raised fractional exhaled nitric oxide (FeNO)
In clinical trials, Dupixent improved lung function and
quality of life, and reduced severe exacerbations and oral
corticosteroid use
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today
announced that the European Commission (EC) approved a new
indication for Dupixent® (dupilumab) in asthma. Dupixent
is now approved in the European Union (EU) for use in 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 fractional exhaled nitric oxide
(FeNO), who are inadequately controlled with high dose inhaled
corticosteroid (ICS) plus another medicinal product for maintenance
treatment.
"People whose severe asthma is inadequately controlled on
current therapy continue to have trouble breathing and suffer
potentially life-threatening exacerbations. This daily burden and
unpredictability can significantly diminish quality of life,
causing missed days of school, work and social activities," said
Tonya Winders, President, Global
Allergy and Asthma Patient Platform (GAAPP). "GAAPP welcomes the
addition of new treatments such as Dupixent, designed to help those
with severe asthma take control of their symptoms and get on with
their daily lives."
Despite standard-of-care treatment, people with severe asthma
often have inadequately controlled, persistent symptoms that may
make them suitable for treatment with a biologic therapy. These
patients live with coughing, wheezing and difficulty breathing, and
are at risk of severe asthma attacks that may require emergency
room visits or hospitalizations. In addition to taking maintenance
ICS treatment, patients with severe asthma often rely on oral
corticosteroids (OCS) when their symptoms worsen. While OCS
treatment can provide relief for severe symptoms, current asthma
guidelines suggest limiting their chronic use to the most severe
patients due to the potential for serious side effects.
"Type 2 inflammation is responsible for many of the hallmark
symptoms of asthma – and Dupixent is the first and only treatment
approved for patients in the European Union with severe asthma
characterized by multiple biomarkers of type 2 inflammation," said
George D. Yancopoulos, M.D., Ph.D.,
President and Chief Scientific Officer at Regeneron. "Dupixent is
now approved in asthma and atopic dermatitis, and we continue to
study this novel treatment in younger populations with these
diseases, as well as other conditions driven by type 2
inflammation, including chronic rhinosinusitis with nasal polyps
and food and environmental allergies."
Dupixent is a human monoclonal antibody that inhibits the
signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two
key proteins that play a central role in type 2 inflammation that
underlies specific types of asthma as well as several other
allergic diseases. This effect is associated with the reduction of
type 2 inflammatory biomarkers including FeNO, immunoglobulin E
(IgE) and eotaxin-3 (CCL26).
"Today's approval marks an important moment for adolescents and
adults in the European Union who suffer from severe asthma with
type 2 inflammation," said John
Reed, M.D., Ph.D., Head of Research and Development at
Sanofi. "In clinical trials, Dupixent not only reduced
exacerbations and oral corticosteroid use, but it also improved
lung function and patients' overall quality of life. Dupixent
offers a new treatment option for those who remain inadequately
controlled with current medications, including those dependent on
oral corticosteroids – which may have potentially serious side
effects when used chronically."
About the LIBERTY ASTHMA Clinical Program
The EC
approval is based on clinical data from 2,888 adults and
adolescents who participated in three pivotal trials from the
global LIBERTY ASTHMA program, including the Phase 3 QUEST and
VENTURE trials and a Phase 2b trial.
QUEST enrolled 1,902 patients with persistent asthma and evaluated
whether adding Dupixent to standard-of-care therapy could reduce
severe exacerbations and improve lung function (measured by
FEV1). VENTURE enrolled 210 patients with severe oral
corticosteroid-dependent asthma and evaluated whether adding
Dupixent to standard-of-care therapy could reduce the use of
maintenance oral corticosteroids. The Phase 2b trial enrolled 776 adult patients with
moderate-to-severe asthma and evaluated whether adding Dupixent to
standard-of-care therapy could improve lung function.
In these trials, Dupixent:
- Reduced severe exacerbations: In QUEST, by week 52
exacerbations were reduced by up to 67% compared to placebo in
patients with eosinophils ≥300 cells/microliter and up to 65% for
those with FeNO levels ≥25 parts per billion. In the Phase
2b trial, by week 24 exacerbations
were reduced by up to 81% compared to placebo in patients with
eosinophils ≥300 cells/microliter.
- Improved lung function: In QUEST, by week 12 Dupixent
improved FEV1 by up to 33% (vs. up to 16% for placebo)
in patients with blood eosinophils of ≥300 cells/microliter and up
to 30% (vs. up to 14% for placebo) in patients with FeNO ≥25 parts
per billion. In the Phase 2b trial,
by week 12 Dupixent improved FEV1 by up to 26% (vs. 10%
for placebo) in patients with blood eosinophils of ≥300
cells/microliter.
- Reduced oral corticosteroid use: In
VENTURE, by week 24 more than half of Dupixent patients completely
eliminated oral corticosteroids, and overall use reduced by 70%
(vs. 42% for placebo).
- Safety: In asthma clinical trials, the most common
adverse reaction was injection site erythema (redness).
Anaphylactic reaction has been reported very rarely in the asthma
development program.
All trials enrolled patients irrespective of minimum baseline
type 2 inflammatory biomarkers, such as eosinophils or FeNO levels.
Recently updated Global Initiative for Asthma (GINA) guidelines
characterize type 2 inflammation as eosinophils ≥150
cells/microliter or FeNO ≥20 parts per billion. In these pivotal
asthma trials, patients with eosinophils ≥150 cells/microliter or
FeNO ≥25 parts per billion benefited most from Dupixent. In the
Phase 2b trial and QUEST, the
greatest improvements in exacerbations and lung function were
observed in patients with higher baseline levels of type 2 disease.
In VENTURE the effect of Dupixent on oral corticosteroid use,
exacerbations and lung function was similar, irrespective of
baseline levels of type 2 inflammation.
About Dupixent
Dupixent is also approved in the EU for
the treatment of adults with moderate-to-severe atopic dermatitis
who are candidates for systemic therapy. In October 2018, Dupixent was approved in the U.S.
as an add-on maintenance therapy in patients with
moderate-to-severe asthma aged 12 years and older with an
eosinophilic phenotype or with oral corticosteroid-dependent
asthma. It is also approved in the U.S. for adults and adolescents
(12 to 17 years of age) with moderate-to-severe atopic dermatitis
whose disease is not adequately controlled with topical
prescription therapies or when those therapies are not advisable.
Dupixent is being developed jointly by Regeneron and Sanofi as part
of a global collaboration agreement.
Dupixent comes in a 200 mg pre-filled syringe for patients with
severe asthma or a 300 mg pre-filled syringe for those who have
severe asthma and are on oral corticosteroids or with co-morbid
moderate-to-severe atopic dermatitis. It is given as a subcutaneous
injection every other week at different injection sites after the
initial loading dose. Dupixent can be given in a clinic or at home
by self-administration after training by a healthcare
professional.
In addition to the currently approved indications, Regeneron and
Sanofi are also studying dupilumab in a broad range of clinical
development programs for diseases driven by allergic and other type
2 inflammation, including chronic rhinosinusitis with nasal polyps
(Phase 3 completed), pediatric 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 3), chronic obstructive pulmonary disease (Phase 3) and food
and environmental allergies (Phase 2). Dupilumab is also being
studied in combination with REGN3500, which targets IL-33. These
potential uses are investigational and the safety and efficacy have
not been evaluated by any regulatory authority. Dupilumab and
REGN3500 were invented using Regeneron's proprietary
VelocImmune® technology that yields optimized
fully-human antibodies.
For more information on dupilumab clinical trials please visit
www.clinicaltrials.gov.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat people 12 years of age and older with
moderate-to-severe atopic dermatitis (eczema) that is not well
controlled with prescription therapies used on the skin (topical),
or who cannot use topical therapies. DUPIXENT can be used with or
without topical corticosteroids. It is not known if DUPIXENT is
safe and effective in children with atopic dermatitis under 12
years of age.
- with other asthma medicines for the maintenance treatment of
moderate-to-severe asthma in people aged 12 years and older
whose asthma is not controlled with their current asthma medicines.
DUPIXENT helps prevent severe asthma attacks (exacerbations) and
can improve your breathing. DUPIXENT may also help reduce the
amount of oral corticosteroids you need while preventing severe
asthma attacks and improving your breathing. DUPIXENT is not used
to treat sudden breathing problems. It is not known if DUPIXENT is
safe and effective in children with asthma under 12 years of
age.
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
Do not use if you are allergic to dupilumab or to
any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about
all your medical conditions, including if you:
- have eye problems (if you also have atopic dermatitis)
- have a parasitic (helminth) infection
- are taking oral, topical, or inhaled corticosteroid medicines.
Do not stop taking your corticosteroid medicines unless
instructed by your healthcare provider. This may cause other
symptoms that were controlled by the corticosteroid medicine to
come back.
- are scheduled to receive any vaccinations. You should not
receive a "live vaccine" if you are treated with DUPIXENT.
- are pregnant or plan to become pregnant. It is not known
whether DUPIXENT will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
whether DUPIXENT passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
herbal supplements. If you are taking asthma medicines, do not
change or stop your asthma medicine without talking to your
healthcare provider.
DUPIXENT can cause serious side
effects, including:
- Allergic reactions (hypersensitivity), including a severe
reaction known as anaphylaxis. Stop using DUPIXENT and tell
your healthcare provider or get emergency help right away if you
get any of the following symptoms: breathing problems, fever,
general ill feeling, swollen lymph nodes, swelling of the face,
mouth and tongue, hives, itching, fainting, dizziness, feeling
lightheaded (low blood pressure), joint pain, or skin rash.
- Eye problems. If you have atopic dermatitis, tell your
healthcare provider if you have any new or worsening eye problems,
including eye pain or changes in vision.
- Inflammation in your blood vessels: Rarely, this can
happen in people with asthma who receive DUPIXENT. This may happen
in people who also take a steroid medicine by mouth that is being
stopped or the dose is being lowered. It is not known whether this
is caused by DUPIXENT. Tell your healthcare provider right away if
you have: rash, shortness of breath, persistent fever, chest pain,
or a feeling of pins and needles or numbness of your arms or
legs.
The most common side effects include injection site
reactions, pain in the throat (oropharyngeal pain) and cold sores
in your mouth or on your lips. Eye and eyelid inflammation,
including redness, swelling and itching have been seen in patients
who have atopic dermatitis.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away. These are not all the
possible side effects of DUPIXENT. Call your doctor for medical
advice about side effects. You are encouraged to report negative
side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. DUPIXENT is an injection
given under the skin (subcutaneous injection). If your healthcare
provider decides that you or a caregiver can give DUPIXENT
injections, you or your caregiver should receive training on the
right way to prepare and inject DUPIXENT. Do not try to
inject DUPIXENT until you have been shown the right way by your
healthcare provider. In adolescents 12 years of age and older, it
is recommended that DUPIXENT be administered by or under
supervision of an adult.
Please see accompanying full Prescribing Information
including Patient Information.
About Regeneron
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, neuromuscular diseases, infectious diseases
and rare diseases.
Regeneron is accelerating and improving the traditional drug
development process through our proprietary
VelociSuite® technologies, such as
VelocImmune® which produces optimized fully-human
antibodies, and ambitious research initiatives such as the
Regeneron Genetics Center, which is conducting one of the largest
genetics sequencing efforts in the world.
For additional information about the company, please visit
www.regeneron.com or follow @Regeneron on Twitter.
About Sanofi
Sanofi is dedicated to supporting people
through their health challenges. We are a global biopharmaceutical
company focused on human health. We prevent illness with vaccines,
provide innovative treatments to fight pain and ease suffering. We
stand by the few who suffer from rare diseases and the millions
with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Regeneron Forward-Looking Statements and Use of Digital
Media
This press release includes forward-looking statements that
involve risks and uncertainties relating to future events and the
future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron"
or the "Company"), and actual events or results may differ
materially from these forward-looking statements. Words such
as "anticipate," "expect," "intend," "plan," "believe," "seek,"
"estimate," variations of such words, and similar expressions are
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now underway or planned, including without limitation
Dupixent® (dupilumab) Injection; the likelihood, timing,
and scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for
marketed products, such as dupilumab for the treatment of pediatric
atopic dermatitis, pediatric asthma, chronic rhinosinusitis with
nasal polyps, eosinophilic esophagitis, food and environmental
allergies, chronic obstructive pulmonary disease, and other
potential indications (as well as in combination with REGN3500);
unforeseen safety issues resulting from the administration of
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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
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privacy; determinations by regulatory and administrative
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ability to continue to develop or commercialize Regeneron's
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Company's products (such as Dupixent) from third-party payers,
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and government programs such as Medicare and Medicaid; coverage and
reimbursement determinations by such payers and new policies and
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and commercial success of Regeneron's products and product
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on the commercial success of any such products and product
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agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries
Ltd. (or their respective affiliated companies, as applicable), to
be cancelled or terminated without any further product success; and
risks associated with intellectual property of other parties and
pending or future litigation relating thereto, including without
limitation the patent litigation proceedings relating to
EYLEA® (aflibercept) Injection, Dupixent, and
Praluent® (alirocumab) Injection, the ultimate outcome
of any such litigation proceedings, and the impact any of the
foregoing may have on Regeneron's business, prospects, operating
results, and financial condition. A more complete description
of these and other material risks can be found in Regeneron's
filings with the U.S. Securities and Exchange Commission, including
its Form 10-K for the year ended December
31, 2018. Any forward-looking statements are made
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is cautioned not to rely on any forward-looking statements made by
Regeneron. Regeneron does not undertake any obligation to
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Regeneron uses its media and investor relations website and
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Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
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Regeneron
Contacts:
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Media
Relations
Sharon
Chen
Tel: +1 (914)
847-1546
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Investor
Relations
Mark
Hudson
Tel: +1 (914)
847-3482
Mark.Hudson@regeneron.com
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Sanofi
Contacts:
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SOURCE Regeneron Pharmaceuticals, Inc.