FDA expands
approval of
Dupixent®
(dupilumab) to include
children aged 6 to 11 years with
moderate-to-severe asthma
- Dupixent is the only biologic medicine to improve lung function
in children aged 6 to 11 years in a randomized Phase 3 trial,
supporting potential as a best-in-class option
- Only biologic medicine approved for children with oral
corticosteroid-dependent asthma
- Data reinforce well-established safety profile of Dupixent
PARIS and TARRYTOWN, N.Y.
– October
20,
2021 - The U.S. Food and Drug
Administration (FDA) has approved Dupixent® (dupilumab) as an
add-on maintenance treatment of patients aged 6 to 11 years with
moderate-to-severe asthma characterized by an eosinophilic
phenotype or with oral corticosteroid-dependent asthma.“This FDA
approval brings new hope for children who may be suffering from
life-threatening asthma attacks and poor lung function, affecting
their ability to breathe, potentially into adulthood,” says Naimish
Patel, M.D. Head of Global Development in Immunology and
Inflammation at Sanofi. “Dupixent has helped to make a difference
to the lives of many patients and families across three diseases
with underlying type 2 inflammation, with more than 300,000
patients treated globally. We now have the opportunity to offer a
safe and effective option to children as young as 6 years of age
living with certain types of moderate-to-severe asthma.”Asthma is
one of the most common chronic diseases in children. Approximately
75,000 children aged 6 to 11 years live with the uncontrolled
moderate-to-severe form of the disease in the U.S., with many more
worldwide. Despite treatment with current standard-of-care inhaled
corticosteroids and bronchodilators, these children may continue to
experience serious symptoms such as coughing, wheezing and
difficulty breathing. They also may require the use of multiple
courses of systemic corticosteroids that carry significant
risks.
“Despite available treatments,
moderate-to-severe asthma can severely impact children’s developing
airways, causing sleepless nights, persistent coughing and
wheezing, and potentially life-threatening exacerbations that
require the use of systemic steroids that can negatively affect
growth,” says George D. Yancopoulos, M.D., Ph.D., President and
Chief Scientific Officer at Regeneron. “This approval means that
Dupixent, a first-of-its-kind treatment with a well-established
efficacy and safety profile, can now be used by younger children
with certain types of moderate-to-severe asthma in the U.S. In our
pivotal trial, Dupixent helped children aged 6 to 11 years breathe
better, suffer fewer asthma attacks and improve health-related
quality of life. We also continue to study Dupixent in patients
with other dermatologic, respiratory and gastrointestinal
conditions, where type 2 inflammation may play a role.”
The FDA approval is based on data from a Phase 3
randomized, double-blind, placebo-controlled trial that evaluated
the efficacy and safety of Dupixent combined with standard-of-care
asthma therapy in children with uncontrolled moderate-to-severe
asthma. More than 90% of children in the trial had at least one
concurrent type 2 inflammatory condition.
Among patients who entered the trial with high
levels of a certain type of white blood cell (eosinophils [EOS]
≥300 cells/μl; n=259), those who added Dupixent (100 mg or 200 mg
every two weeks, based on weight) to standard-of-care
experienced:
- Substantially reduced rate of
severe asthma attacks, with a 65% average reduction over one year
compared to placebo (0.24 events per year for Dupixent vs. 0.67 for
placebo).
- Improved lung function observed as
early as two weeks and sustained for up to 52 weeks, measured by
percent predicted pre-bronchodilator FEV1 (FEV1pp).
- At 12 weeks, patients taking
Dupixent improved their lung function by 5.32 percentage points
compared to placebo.
- Improved asthma control at 24
weeks, with 81% of patients reporting a clinically meaningful
improvement based on disease symptoms and impact compared to 64% of
placebo patients, as measured by a ≥0.5 improvement on a 7-point
scale.
Children with elevated fractional exhaled nitric
oxide (FeNO ≥20 ppb), an airway biomarker of inflammation that
plays a major role in asthma, were also evaluated. In this
subgroup, children who added Dupixent to standard-of-care
experienced a reduction in the rate of severe asthma attacks.
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, with the addition of helminth infections which were
reported in 2.2% of Dupixent patients and 0.7% of placebo patients.
The overall rates of adverse events were 83% for Dupixent and 80%
for placebo. The most common adverse events that were more commonly
observed with Dupixent compared to placebo were injection site
reactions (18% Dupixent, 13% placebo), viral upper respiratory
tract infections (12% Dupixent, 10% placebo) and eosinophilia (6%
Dupixent, 1% placebo).
Dupixent is currently under regulatory review
for children aged 6 to 11 years with moderate-to-severe asthma in
the European Union and other health authorities worldwide.
About the LIBERTY ASTHMA VOYAGE
Trial
The Phase 3 randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent combined with standard-of-care asthma therapy in 408
children aged 6 to 11 years with uncontrolled moderate-to-severe
asthma. In this trial, 86% of children had markers of type 2
inflammation underlying their asthma.
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 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 mean change from baseline in responder rates as measured
by a ≥0.5 improvement on the Asthma Control Questionnaire
7-Interviewer Administered.
About Dupixent
Dupixent is an injection under the skin
(subcutaneous injection) at different injection sites. For
pediatric patients aged 6 to 11 years, Dupixent dosing is based on
weight (100 mg every two weeks or 300 mg every four weeks for
children ≥15 to <30 kg, and 200 mg every two weeks for children
≥30 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 mg 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.
In the U.S., Dupixent is approved as an add-on
maintenance treatment of patients aged 6 years and older with
moderate-to-severe asthma characterized by an eosinophilic
phenotype or with oral-steroid dependent asthma; in patients aged 6
years and older with uncontrolled moderate-to-severe atopic
dermatitis; and for use with other medicines for the maintenance
treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP)
in adults whose disease is not controlled.
Sanofi and Regeneron are committed to helping
patients in the U.S. who are prescribed Dupixent gain access to the
medicine and receive the support they may need with the DUPIXENT
MyWay® program. For more information, please call 1-844-DUPIXENT
(1-844-387-4936) or visit www.DUPIXENT.com.
Dupixent is also approved in Europe, Japan and
other countries around the world for use in certain patients with
asthma or CRSwNP in different age populations, as well as specific
patients with moderate-to-severe atopic dermatitis. Dupixent is
approved in one or more of these indications in more than 60
countries around the world, and more than 300,000 patients have
been treated globally.
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.
IL-4 and IL-13 are key and central drivers of the type 2
inflammation that plays a major role in atopic dermatitis, asthma,
and CRSwNP.
Dupilumab Development
Program
To date, dupilumab has been studied across 60
clinical trials involving more than 10,000 patients with various
chronic diseases driven in part by type 2 inflammation.
Sanofi and Regeneron are studying dupilumab in a
broad range of diseases driven by type 2 inflammation or other
allergic processes, including chronic obstructive pulmonary disease
with evidence of type 2 inflammation (Phase 3), pediatric atopic
dermatitis (6 months to 5 years of age, 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. Dupilumab is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents life-transforming medicines for
people with serious diseases. Founded and led for over 30 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 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.
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