Press Release: FDA approves Dupixent® (dupilumab) as first
treatment for adults and children aged 12 and older with
eosinophilic esophagitis
FDA approves Dupixent® (dupilumab) as first treatment for adults
and children aged 12 and older with eosinophilic esophagitis
- Dupixent is the first and only
medicine indicated to treat eosinophilic esophagitis in the United
States; approval granted more than two months ahead of FDA’s
Priority Review action date
- Dupixent 300 mg weekly
significantly improved signs and symptoms of eosinophilic
esophagitis compared to placebo in a Phase 3 trial, underscoring
the role of type 2 inflammation in this complex disease
- Eosinophilic esophagitis is a
chronic, progressive inflammatory disease driven by type 2
inflammation that damages the esophagus and prevents it from
working properly
- Approval represents first
indication for Dupixent in a gastrointestinal disease and fourth
disease indicated overall
Paris and Tarrytown, N.Y.
May 20, 2022. The U.S. Food and
Drug Administration (FDA) has approved Dupixent® (dupilumab) 300 mg
weekly to treat patients with eosinophilic esophagitis (EoE) aged
12 years and older, weighing at least 40 kg. With this approval,
Dupixent becomes the first and only medicine specifically indicated
to treat EoE in the United States. A regulatory filing for EoE is
under review by the European Medicines Agency, and submissions to
regulatory authorities in additional countries are planned by the
end of 2022.
Mary Jo
StrobelExecutive Director, American Partnership
for Eosinophilic Disorders (APFED)“We have waited a long time for
an FDA-approved treatment option for eosinophilic esophagitis - an
underdiagnosed and misunderstood disease of the esophagus that can
make it extremely challenging and uncomfortable to eat and swallow.
Before today, there were no approved treatments specifically for
eosinophilic esophagitis, resulting in many people needing to
maintain a strict diet and live in constant fear of food getting
stuck in their throat. We welcome therapeutic options that can
provide much-needed relief for these patients.”
EoE is a chronic inflammatory disease driven by
type 2 inflammation that damages the esophagus and prevents it from
working properly. 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. About 160,000 patients are
living with EoE in the U.S. These individuals are currently treated
with therapies not specifically approved for the disease, of whom
approximately 48,000 continue to experience symptoms despite
multiple treatments.
John Reed, M.D., Ph.D.Global
Head of Research and Development, Sanofi“Eating regularly
throughout the day is essential, yet significant difficulty
swallowing food is a common symptom for people living with
eosinophilic esophagitis. This can be incredibly upsetting and
often leads to fear of pain or choking with every meal, every day.
A large unmet need exists for treatment options that can provide
meaningful symptom relief. Our Phase 3 clinical program showed that
Dupixent weekly improved the ability to swallow and reduced
inflammation in the esophagus, underscoring the role of type 2
inflammation in this complex disease. This is a landmark FDA
approval for patients and their caregivers who now have a new
option for treating this devastating disease.”
George D.
Yancopoulos, M.D., Ph.D.President
and Chief Scientific Officer, Regeneron“It is gratifying that
Dupixent, a medicine that we invented in our laboratories, is now
approved in yet another disease marked by allergic or type 2
inflammation, namely eosinophilic esophagitis. Eosinophilic
esophagitis can be debilitating for patients, by inflaming and
damaging the esophagus and limiting the ability to eat normally.
Dupixent is the first and only medicine specifically indicated to
treat eosinophilic esophagitis in the United States, and today’s
approval marks the fourth disease for which Dupixent is now
indicated, reinforcing the promise of targeting IL-4 and IL-13 to
effectively treat diseases with underlying type 2
inflammation.”
The FDA approval is based on data from a Phase 3
trial with two parts (Part A and Part B) evaluating the efficacy
and safety of Dupixent 300 mg weekly, compared to placebo, in
patients aged 12 years and older with EoE, weighing at least 40 kg.
After 24 weeks, patients treated with Dupixent 300 mg weekly
experienced the following changes in Part A and Part B,
respectively:
- 69% and 64% reduction in disease
symptoms from baseline compared to 32% and 41% for placebo. Disease
symptoms were measured by the Dysphagia Symptom Questionnaire
(DSQ), where patients receiving Dupixent experienced a 21.9- and
23.8-point clinically meaningful improvement compared to 9.6- and
13.9-point improvement for placebo.
- Approximately 10 times as many
patients achieved histological disease remission (peak esophageal
intraepithelial eosinophil count of ≤6 eos/high power field [hpf])
compared to placebo: 60% and 59% compared to 5% and 6% of patients
receiving placebo.
The safety results were generally consistent
with the known safety profile of Dupixent in its approved
indications. Pooled adverse events from Parts A and B that were
more commonly (≥2%) observed with Dupixent than placebo were
injection site reactions (38% Dupixent, 33% placebo), upper
respiratory tract infections (18% Dupixent, 10% placebo),
arthralgia (2% Dupixent, 1% placebo) and herpes viral infections
(2% Dupixent, 1% placebo).
The FDA evaluated the Dupixent application under
Priority Review, which is granted to therapies that have the
potential to provide significant improvements in the treatment,
diagnosis or prevention of serious conditions.
About the
Dupixent Eosinophilic Esophagitis
Trial
The Phase 3 randomized, double-blind,
placebo-controlled trial evaluated the efficacy and safety of
Dupixent in patients aged 12 years and older with EoE. Part A
enrolled 81 patients and evaluated Dupixent 300 mg weekly (42
treated with Dupixent and 39 with placebo). Part B enrolled 159
patients and evaluated Dupixent 300 mg weekly (80 with Dupixent and
79 with placebo).
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).
About Dupixent
Dupixent is administered as an injection under
the skin (subcutaneous injection) at different injection sites. In
patients aged 12 years and older, weighing at least 40 kg, with
EoE, Dupixent is administered as a 300 mg dose with a pre-filled
syringe or pen every week. 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 aged 12 to 17 years, Dupixent should be
administered under the supervision of an adult.
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 asthma, atopic dermatitis, chronic
rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic
esophagitis, as well as investigational diseases such as prurigo
nodularis.
Regeneron and Sanofi 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 for use in certain
patients with atopic dermatitis, asthma or CRSwNP in different age
populations in a number of countries around the world, including
the U.S., European Union and Japan. Dupixent is currently approved
for one or more of these indications in more than 60 countries, and
more than 400,000 patients have been treated 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 including pediatric atopic dermatitis (6 months to 5
years of age, Phase 3), hand and foot atopic dermatitis (Phase 3),
chronic obstructive pulmonary disease with evidence of type 2
inflammation (Phase 3), pediatric eosinophilic esophagitis (Phase
3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3),
chronic spontaneous urticaria (Phase 3), chronic pruritis of
unknown origin (Phase 3), chronic inducible urticaria-cold (Phase
3), chronic rhinosinusitis without nasal polyposis (Phase 3),
allergic fungal rhinosinusitis (Phase 3) and allergic
bronchopulmonary aspergillosis (Phase 3). 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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