Dupixent® (dupilumab)
Approved for Severe Asthma by European Commission
-
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
PARIS and
TARRYTOWN, NY - May 7, 2019 - The European Commission has
approved Dupixent® (dupilumab)
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 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 by eosinophils >=150 cells/microliter or FeNO
>=20 parts per billion. In these pivotal 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.
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
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ir@sanofi.com
Regeneron Investor Relations Contact
Mark Hudson
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Mark.Hudson@regeneron.com
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