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
ProgramThe 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 DupixentDupixent 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 SanofiSanofi 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
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globe.Sanofi, Empowering Life |
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