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 CSUCSU 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 DupixentDupixent (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
programDupilumab 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 RegeneronRegeneron (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,
Instagram, Facebook or X.
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 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
Sanofi Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25 |
sandrine.guendoul@sanofi.comEvan
Berland | + 1 215 432 0234
| evan.berland@sanofi.comVictor Rouault | +
33 6 70 93 71 40 | victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
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felix.lauscher@sanofi.comKeita
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keita.browne@sanofi.comNathalie Pham | +
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Regeneron Media RelationsIlana
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Regeneron Investor RelationsMark
Hudson | + 914-847-3482 | mark.hudson@regeneron.com
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release as well as the treatment of chronic pruritus of unknown
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