New England Journal of Medicine publishes positive Phase 3
Dupixent® (dupilumab) results in children with moderate-to-severe
asthma
New England Journal of Medicine
publishes
positive Phase 3
Dupixent® (dupilumab) results in
children with moderate-to-severe asthma
- Dupixent significantly reduced severe asthma attacks and
improved lung function and asthma control in children aged 6 to 11
years with uncontrolled moderate-to-severe asthma
- Published results reinforce well-established safety profile of
Dupixent
- Positive data formed the basis for FDA approval of Dupixent in
these patients with certain types of moderate-to-severe asthma and
regulatory reviews are ongoing in the European Union
PARIS and TARRYTOWN, N.Y.
– December
8, 2021 - The
New England Journal of Medicine has published positive results from
a pivotal Dupixent® (dupilumab) clinical trial in children aged 6
to 11 years with uncontrolled moderate-to-severe asthma. These data
formed the basis for the FDA approval of Dupixent on October 20,
2021 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.
These published results showed Dupixent, when
added to standard of care, significantly reduced severe asthma
attacks and, within two weeks, rapidly improved lung function in
populations with an eosinophilic phenotype, as indicated by
elevated blood eosinophils, a certain type of white blood cell,
and/or with elevated fractional exhaled nitric oxide (FeNO), an
airway biomarker of inflammation that plays a major role in
asthma.“The publication of these Phase 3 results for Dupixent in
the New England Journal of Medicine underscore their significance
and potential clinical value for younger children with uncontrolled
moderate-to-severe asthma,” says Leonard B. Bacharier, M.D.,
Professor of Pediatrics and Director of the Center for Pediatric
Asthma Research, Monroe Carell Jr. Children's Hospital at
Vanderbilt University Medical Center in Nashville, Tennessee, and
principal investigator of the trial. “These data also further our
understanding of how addressing type 2 inflammation, a biological
process that underlies most cases of childhood asthma, can
potentially improve symptoms and outcomes for children suffering
from this common chronic disease.”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., and 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 multiple courses of systemic corticosteroids that
can carry significant safety risks.
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 that 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 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 chronic rhinosinusitis with nasal polyposis (CRSwNP).
The results of this Phase 3 trial were also
included in the European regulatory filing, and a decision from the
European Medicines Agency in children with uncontrolled severe
asthma is expected in Q1 2022.
About the LIBERTY ASTHMA VOYAGE
trial
The Phase 3 randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent (100 mg for children ≤30 kg or 200 mg for children >30
kg every two weeks) combined with standard-of-care asthma therapy
in 408 children aged 6 to 11 years with uncontrolled
moderate-to-severe 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 percentage of
predicted pre-bronchodilator FEV1 (ppFEV1) at week 12.
About Dupixent
Dupixent is currently approved in the U.S.,
Europe, Japan and other countries around the world for use in
specific patients with moderate-to-severe atopic dermatitis, as
well as certain patients with asthma or 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 300,000 patients have been treated globally.
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.
Dupilumab Development
Program
Dupilumab is being jointly developed by Sanofi
and Regeneron under a global collaboration agreement. 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.
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 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.
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.
Sanofi Media Relations
ContactSally BainTel.: +1 (781)
264-1091Sally.Bain@sanofi.com
Regeneron Media Relations
ContactSharon
Chen Tel.:
+1 (914) 847-1546Sharon.Chen@regeneron.com
Sanofi Investor
Relations Contacts ParisEva Schaefer-JansenArnaud
DelepineNathalie Pham
Sanofi Investor
Relations Contact North AmericaFelix Lauscher
Tel.: +33 (0)1 53 77 45
45 investor.relations@sanofi.com
https://www.sanofi.com/en/investors/contact
Regeneron Investor
RelationsVesna
Tosic Tel.:
+1 (914) 847-5443Vesna.Tosic@regeneron.com
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