Press Release: Dupixent sBLA accepted for FDA review for the
treatment of chronic spontaneous urticaria
Dupixent sBLA accepted for FDA review for the
treatment of chronic spontaneous urticaria
- Resubmission includes new pivotal data
which confirm Dupixent significantly reduced itch and hive
activity
- More than 300,000 people in the US
suffer from chronic spontaneous urticaria (CSU) that is
inadequately controlled by antihistamines
- FDA decision expected by April 18,
2025; if approved, Dupixent would be the first targeted therapy for
CSU in a decade
Paris and Tarrytown, NY, November 15,
2024. The US Food and Drug Administration (FDA) has
accepted for review the resubmission of the supplemental biologics
license application (sBLA) for Dupixent (dupilumab) to treat adults
and pediatric patients aged 12 years and older with chronic
spontaneous urticaria (CSU) whose disease is not adequately
controlled with H1 antihistamine treatment. The target action date
for the FDA decision is April 18, 2025.
The resubmitted sBLA is supported by data from the
multi-study LIBERTY-CUPID phase 3 clinical program (Study A, Study
B, and Study C) for Dupixent in CSU. The sBLA adds results from
Study C, which was conducted in patients with uncontrolled CSU who
were on standard-of-care antihistamines. Study C, the second
LIBERTY-CUPID pivotal study in biologic-naïve patients, met its
primary and key secondary endpoints, confirming results seen in the
previous Study A. Results showed Dupixent significantly reduced
itch and urticaria activity (itch and hives).
Safety results in all LIBERTY-CUPID phase 3 studies
were generally consistent with the known safety profile of Dupixent
in its approved indications. Adverse events more commonly observed
with Dupixent (≥5%) compared to placebo were injection site
reactions and COVID-19 infection.
About CSU
CSU is a chronic inflammatory skin disease driven in part by type-2
inflammation, which causes sudden and debilitating hives and
recurring itch. CSU is typically treated with H1 antihistamines,
medicines that target H1 receptors on cells to control symptoms of
urticaria. However, the disease remains uncontrolled despite
antihistamine treatment in many patients, some of whom are left
with limited alternative treatment options. These individuals
continue to experience symptoms that can be debilitating and
significantly impact their quality of life. More than 300,000
people in the US suffer from CSU that is inadequately controlled by
antihistamines.
About Dupixent in CSU
The LIBERTY-CUPID Phase 3 study program evaluating Dupixent for CSU
consists of Study A, Study B, and Study C. Study A and Study C were
conducted in CSU patients who were uncontrolled on standard-of-care
antihistamines while Study B was conducted in CSU patients who were
uncontrolled on standard-of-care antihistamines and refractory or
intolerant to omalizumab.
Dupixent has been approved for CSU in Japan and the
United Arab Emirates (UAE) and is also under regulatory review in
the EU based on earlier study readouts. Outside of Japan and the
UAE, the safety and efficacy of Dupixent for CSU has not been fully
evaluated by any regulatory authority.
About Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that
inhibits the signaling of the IL4 and IL13 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 studies, establishing that IL4 and IL13 are two of the
key and central drivers of type-2 inflammation that play a major
role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more
than 60 countries in one or more indications including certain
patients with atopic dermatitis, asthma, chronic rhinosinusitis
with nasal polyps, eosinophilic esophagitis, prurigo nodularis,
CSU, and chronic obstructive pulmonary disease in different age
populations. More than 1,000,000 patients are currently being
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 studies 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 in part by type-2 inflammation or other allergic
processes in phase 3 studies, including chronic pruritus of unknown
origin 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 by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
approved treatments and product candidates in development, most 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, neurological diseases, hematologic conditions, infectious
diseases, and rare diseases.
Regeneron pushes the boundaries of scientific
discovery and accelerates drug development using our proprietary
technologies, such
as VelociSuite®, which
produces optimized fully human antibodies and new classes of
bispecific antibodies. We are shaping the next frontier of medicine
with data-powered insights from the Regeneron Genetics
Center® and pioneering genetic medicine
platforms, enabling us to identify innovative targets and
complementary approaches to potentially treat or cure diseases.
For more information, please visit
www.Regeneron.com or follow Regeneron on LinkedIn,
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About Sanofi
We are an innovative global healthcare company, driven by one
purpose: we chase the miracles of science to improve people’s
lives. Our team, across the world, 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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