Dupixent® (dupilumab) approved by European Commission as
the first and only targeted medicine indicated for eosinophilic
esophagitis
- Approximately 60% of patients aged
12 years and older treated with Dupixent 300 mg weekly in the
pivotal trial experienced histological disease remission; patients
also significantly improved their ability to swallow compared to
placebo
-
Dupixent is now an option for the approximately 50,000 adults and
adolescents living with severe uncontrolled eosinophilic
esophagitis in the European Union (EU)
- Dupixent now approved to treat five
diseases with underlying type 2 inflammation in the EU
Paris and Tarrytown,
N.Y. Jan 30,
2023. The European
Commission (EC) has expanded the marketing authorization for
Dupixent® (dupilumab) in the European Union (EU) to treat
eosinophilic esophagitis (EoE) in adults and adolescents 12 years
and older, weighing at least 40 kg, who are inadequately controlled
by, are intolerant to, or who are not candidates for conventional
medicinal therapy. EoE is a chronic, progressive inflammatory
disease that damages the esophagus and prevents it from working
properly. With this approval, Dupixent is the first and only
targeted medicine specifically indicated to treat EoE in Europe and
the U.S.
Naimish
Patel, M.D. Head of Global
Development, Immunology and Inflammation at Sanofi “The
impact of EoE on a patient’s daily life cannot be overstated – the
narrowing and scarring of the esophagus can make something as
simple as eating a painful and distressing experience, and may lead
to choking and food impaction. With this latest approval for
Dupixent, adults and adolescents in the EU suffering from the
chronic and often debilitating symptoms of EoE now have the first
and only targeted treatment option clinically proven to reduce both
esophageal inflammation and damage, as well as improve swallowing
ability, pain and health-related quality of life.”
George D. Yancopoulos, M.D.,
Ph.D. President and Chief Scientific Officer at
Regeneron “This latest approval establishes Dupixent as the
only targeted medicine specifically indicated for eosinophilic
esophagitis in the European Union. Dupixent is also the only
biologic shown in pivotal trials to help patients achieve
histological remission, reduce difficulty swallowing and improve
health-related quality of life – all of which are crucial to
reducing the burden of this debilitating disease. Since its first
approval, Dupixent has redefined the treatment of certain chronic
diseases with underlying type 2 inflammation and is now indicated
for five conditions in the European Union. We remain committed to
investigating Dupixent’s potential in additional diseases in which
IL-4 and IL-13 may play a key role.”
The EC decision is supported by 52-week data
from a Phase 3 trial consisting of three parts (Part A, B and C).
Part A and Part B investigated Dupixent 300 mg weekly (Part A n=42;
Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24
weeks. Part C (n=188) observed patients who had continued on or
switched to Dupixent from Parts A and B for an additional 28
weeks.
Dupixent patients in Parts A and B,
respectively, experienced:
- An approximately
10 times higher rate of histological disease remission (60% and
59%), a co-primary endpoint, compared to placebo (5% and 6%).
- A 69% and 64%
reduction in disease symptoms compared to 32% and 41% with placebo.
Disease symptoms were measured using the Dysphagia Symptom
Questionnaire (DSQ), on which Dupixent patients experienced a 21.9-
and 23.8-point clinically meaningful improvement compared to a 9.6-
and 13.9-point improvement for placebo, a co-primary endpoint.
Swallowing improvement was observed as early as four weeks.
- A greater than
seven-fold reduction in abnormal endoscopic findings from baseline
(-3.2 and -4.5 points) compared to placebo (-0.3 and -0.6
points).
- Nominally
significant improvements in swallowing-related pain and
health-related quality of life, as well as less frequent
non-swallowing symptoms.
Histological disease remission, swallowing
improvement and reduction in abnormal endoscopic findings were
consistent with the overall population in patients who were
uncontrolled, or not responsive to or not eligible for swallowed
topical corticosteroids. Longer term efficacy in Part C was similar
to results observed in Parts A and B.
The safety results of the trial were generally
consistent with the known safety profile of Dupixent in its
approved indications. The most common side effects across
indications include injection site reactions, conjunctivitis,
conjunctivitis allergic, arthralgia, oral herpes and eosinophilia.
Adverse events more commonly observed in EoE patients treated with
Dupixent (n=122) compared to placebo (n=117) included infections
(32% vs. 25%). An additional adverse reaction of injection site
bruising was reported in the EoE trial. The safety profile through
52 weeks was generally consistent with the safety profile observed
at 24 weeks.
About Eosinophilic
Esophagitis
EoE is a chronic, progressive inflammatory
disease that damages the esophagus and prevents it from working
properly. The results seen with Dupixent in adults and adolescents
with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13
(IL-13) are key and central drivers of the type 2 inflammation
underlying this disease. For people with EoE, swallowing even small
amounts of food can be a painful and worrisome choking experience.
They are often left to contend with the frustration and anxiety of
a constantly evolving list of foods to avoid, a poor quality of
life and a higher risk of depression. In cases where EoE causes the
esophagus to narrow, forced and potentially painful dilation
(physical expansion) of the esophagus may be needed. In severe
cases, a feeding tube may be the only option to ensure proper
caloric intake and adequate nutrition. In the EU, about 50,000
adults and adolescents live with severe uncontrolled EoE.
About the Dupixent Eosinophilic
Esophagitis Trial
The three-part Phase 3 randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent in patients aged 12 years and older with EoE. All patients
had previously not responded to proton pump inhibitors, and, across
Parts A and B, 74% of patients were previously treated with
swallowed topical corticosteroids.
At 24 weeks, the co-primary endpoints in Parts A
and B assessed patient-reported measures of difficulty swallowing
(change from baseline in the DSQ on a 0-84 scale) and esophageal
inflammation (proportion of patients achieving histological disease
remission, defined as peak esophageal intraepithelial eosinophil
count of ≤6 eos/hpf).
Additional endpoints included abnormal
endoscopic findings (EoE Endoscopic Reference Score [EoE-EREFS] on
a 0-18 scale), swallowing-related pain (DSQ pain score),
health-related quality of life (EoE Impact Questionnaire [EoE-IQ])
and frequency of other non-dysphagia symptoms (EoE Symptom
Questionnaire [EoE-SQ]).
About Dupixent
Dupixent is an injection administered under the
skin (subcutaneous injection) at different injection sites. In the
EU for adolescents and adults with EoE, Dupixent is administered at
300 mg every week. It is available as both a pre-filled pen and
pre-filled syringe at the 300 mg dose. 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.
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 development program has shown significant clinical
benefit and a decrease in type 2 inflammation in Phase 3 trials,
establishing that IL-4 and IL-13 are key and central drivers of the
type 2 inflammation that plays a major role in multiple related and
often co-morbid diseases. These diseases include approved
indications for Dupixent, such as atopic dermatitis, asthma,
chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo
nodularis and EoE.
Dupixent has received regulatory approvals in
one or more countries around the world for use in certain patients
with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in
different age populations. Dupixent is currently approved for one
or more of these indications in more than 60 countries, including
in Europe, the U.S. and Japan. More than 500,000 patients have been
treated with Dupixent globally.
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 in Phase 3 trials, including pediatric EoE, hand and foot
atopic dermatitis, chronic inducible urticaria-cold, chronic
spontaneous urticaria, chronic pruritus of unknown origin, chronic
obstructive pulmonary disease with evidence of type 2 inflammation,
chronic rhinosinusitis without nasal polyposis, allergic fungal
rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous
pemphigoid. 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, develops and commercializes
life-transforming medicines for people with serious diseases.
Founded and led for 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 more information, 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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