Dupixent® (dupilumab) approved by European
Commission for children aged 6 to 11 years with severe asthma with
type 2 inflammation
- Dupixent is the only biologic indicated in the European Union
for severe asthma with type 2 inflammation, characterized by raised
blood eosinophils and/or raised fractional exhaled nitric oxide
- Approval based on Phase 3 data showing Dupixent significantly
reduced severe asthma attacks and also improved lung function and
health-related quality of life for children
- Data reinforce well-established safety profile of Dupixent
Paris and Tarrytown, N.Y. April 7,
2022. The European Commission (EC) has expanded the
marketing authorization for Dupixent® (dupilumab) in the European
Union. Dupixent is now also approved in children aged 6 to 11 years
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 medium to high dose inhaled corticosteroids (ICS)
plus another medicinal product for maintenance treatment.
Naimish Patel, M.D.Head of
Global Development, Immunology and Inflammation, Sanofi “We
are excited to bring the well-established safety and efficacy of
Dupixent to even younger patients living with uncontrolled severe
asthma in Europe. In addition to greatly reducing severe asthma
attacks and improving lung function, patients in our clinical trial
also reduced their oral corticosteroid use. This is particularly
meaningful as these are medicines that can carry significant safety
risks if used long term. This approval underscores our continued
commitment to bringing Dupixent to as many patients as possible
suffering from the negative effects of severe asthma with the hope
of improving their quality of life.”
Asthma is one of the most common chronic
diseases in children. Up to 85% of children with asthma may have
type 2 inflammation and are more likely to have higher disease
burden. Despite treatment with current standard-of-care ICS and
bronchodilators, these children may continue to experience serious
symptoms such as coughing, wheezing and difficulty breathing.
Severe asthma may impact children's developing airways and cause
potentially life-threatening exacerbations. Children with severe
asthma also may require the use of multiple courses of systemic
corticosteroids that carry significant risks. Uncontrolled severe
asthma can interfere with day-to-day activities, like sleeping,
attending school and playing sports.
Dupixent is a fully human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) pathways and is not an immunosuppressant.
The Dupixent Phase 3 clinical program, which has shown significant
clinical benefit and a decrease in type 2 inflammation, has
established that IL-4 and IL-13 are key and central drivers of the
type 2 inflammation that plays a major role in in multiple related
and often co-morbid diseases.
George D. Yancopoulos, M.D.,
Ph.D.President and Chief Scientific Officer,
Regeneron “Today’s approval in Europe recognizes the benefits
of Dupixent in helping children living with the profound effects of
severe asthma, including unpredictable asthma attacks, routine
disruption to daily activities and the use of systemic steroids
that can impede children’s growth. Dupixent is the only treatment
available that specifically blocks two key drivers of type 2
inflammation, IL-4 and IL-13, which our trials show plays a major
role in childhood asthma, as well as in related conditions such as
chronic rhinosinusitis with nasal polyposis and the often co-morbid
condition, atopic dermatitis. In clinical trials, Dupixent
significantly reduced asthma attacks, helped children breathe
better and improved their health-related quality of life. We also
remain committed to investigating Dupixent in other conditions
where type 2 inflammation may significantly impact patients’ lives,
including eosinophilic esophagitis, prurigo nodularis and chronic
spontaneous urticaria.”
The EC decision is based on pivotal data from
the Phase 3 VOYAGE trial evaluating the efficacy and safety of
Dupixent combined with standard-of-care asthma therapy in 408
children with uncontrolled moderate-to-severe asthma.
Two pre-specified populations with evidence of
type 2 inflammation were evaluated for the primary analysis: 1)
patients with baseline blood eosinophils (EOS) ≥300 cells/μl
(n=259) and 2) patients with either baseline FeNO ≥20 parts per
billion (ppb) or baseline blood EOS ≥150 cells/μl (n=350). Patients
who added Dupixent to standard-of-care in these two groups,
respectively, experienced:
- Substantially reduced rates of severe asthma attacks, with a
65% and 59% average reduction over one year compared to placebo
(0.24 and 0.31 events per year for Dupixent vs. 0.67 and 0.75 for
placebo, respectively).
- Improved lung function observed as early as two weeks and
sustained for up to 52 weeks, measured by percent predicted FEV1
(FEV1pp).
- At 12 weeks, patients taking Dupixent improved their lung
function by 5.32 and 5.21 percentage points compared to placebo,
respectively.
- Improved asthma control, with 81% and 79% of patients reporting
a clinically meaningful improvement at 24 weeks, based on disease
symptoms and impact compared to 64% and 69% of placebo patients,
respectively.
- Improved health-related quality of life, with 73% and 73% of
patients reporting a clinically meaningful improvement at 24 weeks,
compared to 63% and 65% of placebo patients, respectively.
- Reduced systemic corticosteroid use by an average of 66% and
59% over one year compared to placebo (0.27 and 0.35 courses per
year for Dupixent vs. 0.81 and 0.86 for placebo,
respectively).
The safety results
from the trial were generally consistent with the known safety
profile of Dupixent in patients aged 12 years and older with
uncontrolled moderate-to-severe asthma. The overall rates of
adverse events were 83% for Dupixent and 80% for placebo. Adverse
events that were more commonly observed with Dupixent compared to
placebo included injection site reactions (18% Dupixent, 13%
placebo), viral upper respiratory tract infections (12% Dupixent,
10% placebo) and eosinophilia (7% Dupixent, 1% placebo). Helminth
infections were also more commonly observed with Dupixent in
patients aged 6 to 11 years and were reported in 2% of Dupixent
patients and 0% of placebo patients.
About the
LIBERTY ASTHMA VOYAGE Trial
The Phase 3
randomized, double-blind, placebo-controlled trial evaluated the
efficacy and safety of Dupixent (100 mg or 200 mg every two weeks,
based on weight tier) combined with standard-of-care asthma therapy
in 408 children aged 6 to 11 years with uncontrolled
moderate-to-severe asthma. More than 90% of children in the trial
had at least one concurrent atopic medical condition such as
allergic rhinitis and atopic dermatitis.
The primary endpoint
was the annualized rate of severe asthma exacerbations over one
year, and the key secondary endpoint was the change from baseline
in percentage of predicted pre-bronchodilator FEV1 (FEV1pp) at week
12. The FEV1pp seeks to evaluate a patient's change in lung
function compared to their predicted lung function based on age,
height, sex and ethnicity to account for children's growing lung
capacity at different stages of development. Additional secondary
endpoints included responder rates for asthma control as measured
by a ≥0.5 improvement on the Asthma Control Questionnaire-7
Interviewer Administered (ACQ-7-IA; 7-point scale) and
health-related quality of life as measured by a ≥0.5 improvement on
the Pediatric Asthma Quality of Life Questionnaire with
Standardized Activities-Interviewer Administered (PAQLQ(S)-IA;
7-point scale).
About
Dupixent
Dupixent is also
approved in Europe, U.S., Japan and other countries around the
world for use in certain patients with asthma, specific patients
with moderate-to-severe atopic dermatitis as well as CRSwNP in
different age populations. Dupixent is also approved in one or more
of these indications in more than 60 countries around the world,
and more than 400,000 patients have been treated globally.
Dupixent is an
injection under the skin (subcutaneous injection) at different
injection sites. In the EU for pediatric patients aged 6 to 11
years, Dupixent dosing is based on weight tier (100 mg every two
weeks or 300 mg every four weeks for children ≥15 to <30 kg, 200
mg every two weeks or 300 mg every four weeks for children ≥30 to
<60 kg and 200 mg every two weeks for children ≥60 kg) and is
supplied as a pre-filled syringe. It is also available as a
pre-filled pen for adolescents (12 to 17 years) and adults at 200
and 300 mg doses. Dupixent is intended for use under the guidance
of a healthcare professional and can be given in a clinic or at
home by self-administration after training by a healthcare
professional. In children younger than 12 years of age, Dupixent
should be administered by a caregiver if given at home.
Dupilumab
Development Program
Dupilumab is being
jointly developed by Sanofi and Regeneron under a global
collaboration agreement. To date, dupilumab has been studied across
more than 60 clinical trials involving more than 10,000 patients
with various chronic diseases driven in part by type 2
inflammation.
In addition to the
currently approved indications, Sanofi and Regeneron are studying
dupilumab in a broad range of diseases driven by type 2
inflammation or other allergic processes including pediatric atopic
dermatitis (6 months to 5 years of age, Phase 3), chronic
obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid
(Phase 3), prurigo nodularis (Phase 3), chronic spontaneous
urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3),
chronic rhinosinusitis without nasal polyposis (Phase 3), allergic
fungal rhinosinusitis (Phase 3), allergic bronchopulmonary
aspergillosis (Phase 3) and peanut allergy (Phase 2). These
potential uses of dupilumab are currently under clinical
investigation, and the safety and efficacy in these conditions have
not been fully evaluated by any regulatory authority.
About
Regeneron
Regeneron (NASDAQ:
REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for nearly 35 years by physician-scientists, our
unique ability to repeatedly and consistently translate science
into medicine has led to nine FDA-approved treatments and numerous
product candidates in development, almost 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, hematologic conditions, 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 SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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