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 addon 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-ofcare 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-tosevere 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 lifetransforming 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.

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