Press Release: Japan first in the world to approve Dupixent® for
chronic spontaneous urticaria (CSU)
Japan first in the world to approve Dupixent® for chronic
spontaneous urticaria (CSU)
- Approval based primarily on results
from Phase 3 trial showing Dupixent significantly reduced itch
compared to placebo
- CSU is the fifth approved indication
for Dupixent in Japan and the sixth indication for Dupixent
globally
Paris and Tarrytown, N.Y. February 16,
2024. The Ministry of Health, Labor and Welfare (MHLW) in
Japan has granted marketing and manufacturing authorization for
Dupixent® (dupilumab) for the treatment of chronic spontaneous
urticaria (CSU) in people aged 12 years and older whose disease is
not adequately controlled with existing therapy. Japan is the first
country to approve Dupixent for CSU, emphasizing the value of
Dupixent as a novel treatment option to manage this disease in
patients with unmet needs.
CSU is a chronic inflammatory skin disease
driven in part by type 2 inflammation, which causes sudden and
debilitating hives and persistent itch. CSU is typically treated
with histamine (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. Approximately 110,000 people aged 12 years and
older suffer from uncontrolled moderate-to-severe CSU in Japan, for
which there are currently limited treatments.
The Japanese approval is based primarily on data
from Study A of the LIBERTY-CUPID clinical trial program evaluating
Dupixent as an add-on therapy to standard-of-care H1 antihistamines
compared to antihistamines alone (placebo) in 138 patients with CSU
who remained symptomatic despite antihistamine use and were not
previously treated with omalizumab. This study met the primary and
all key secondary endpoints. Patients taking Dupixent added to
standard-of-care antihistamines experienced a significant reduction
in itch severity compared to standard of care alone at 24 weeks.
The safety profile of Dupixent in CSU was generally consistent with
the known safety of Dupixent in its approved dermatological
indications.
In addition to CSU, Dupixent is approved in
Japan in certain patients with atopic dermatitis, asthma, chronic
rhinosinusitis with nasal polyposis (CRSwNP), and prurigo
nodularis.
About Dupixent
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,
CRSwNP, prurigo nodularis and eosinophilic esophagitis (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, prurigo nodularis, and
CSU in different age populations. Dupixent is currently approved
for one or more of these indications in more than 60 countries,
including in Japan, Europe and the U.S. More than 800,000 patients
are being treated with Dupixent globally.
The potential use of Dupixent in CSU is under
clinical development in additional countries around the world, and
its safety and efficacy have not been fully evaluated by any
regulatory authority outside of Japan.
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 chronic pruritus of unknown
origin, chronic obstructive pulmonary disease (COPD) with evidence
of type 2 inflammation, 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 SanofiWe are an innovative global
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NASDAQ: SNY.
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 for over 35 years by
physician-scientists, our unique ability to repeatedly and
consistently translate science into medicine has led to numerous
FDA-approved treatments and 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,
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Regeneron is accelerating and improving the
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