Press Release: Dupixent late-breaking positive phase 3 data in
chronic spontaneous urticaria to be presented at ACAAI
Dupixent late-breaking positive phase 3 data in
chronic spontaneous urticaria to be presented at ACAAI
- Dupixent significantly reduced itch
and hive activity from baseline; 41% of patients achieved
well-controlled disease status
- Confirmatory data to support US
regulatory resubmission by year-end; if approved, Dupixent would be
the first new targeted treatment for people living with chronic
spontaneous urticaria in more than 10 years
- More than 300,000 people in the US
suffer from chronic spontaneous urticaria that is inadequately
controlled by antihistamines
Paris and Tarrytown, NY, October 24,
2024. Positive data from the phase 3 LIBERTY-CUPID Study C
evaluating the investigational use of Dupixent (dupilumab) in
biologic-naive patients with uncontrolled chronic spontaneous
urticaria (CSU) who receive background therapy with antihistamines
will be presented in a late-breaking oral presentation at the
American College of Allergy, Asthma and Immunology (ACAAI) 2024
Annual Scientific Meeting in Boston, Massachusetts. Results showed
treatment with Dupixent significantly reduced itch and urticaria
activity (itch and hive) scores from baseline, and a higher
proportion of patients achieved well-controlled disease status,
compared to placebo.
Thomas B. Casale,
M.D.
Professor, Internal Medicine, Morsani College of Medicine at the
University of South Florida, USA
“Chronic spontaneous urticaria is an inflammatory skin
condition that affects patients with unpredictable episodes of
intense itching and hives, often severely impacting their daily
lives. These data confirm results seen in the previous Study A and
reinforce the potential of Dupixent to significantly alleviate
symptoms for patients, helping them to better control this
challenging disease.”
Study C enrolled 151 children and adults who were
randomized to receive Dupixent (n=74) or placebo (n=77) added to
standard-of-care histamine-1 (H1) antihistamines. At 24 weeks,
Dupixent demonstrated significant improvements compared to placebo
on:
- Itch severity score (8.64- vs.
6.10-point reduction from baseline; p=0.02)
- Urticaria (itch and hive) activity
score (15.86- vs. 11.21-point reduction from baseline; p=0.02)
- Well-controlled disease status
(urticaria activity score ≤6; 41% vs. 23%; p=0.005)
- Complete response (urticaria activity
score=0; 30% vs. 18%; p=0.02)
The safety results in Study C were generally
consistent with the known safety profile of Dupixent in its
approved dermatological indications. Overall rates of treatment
emergent adverse events (AEs) were 53% for both Dupixent and
placebo. AEs more commonly observed with Dupixent (≥5%) compared to
placebo included injection site reactions (12% vs. 4%), accidental
overdose (7% vs. 3%) and COVID-19 infection (8% vs. 5%).
Dupixent has been approved for CSU in Japan, the
United Arab Emirates (UAE) and is also under regulatory review in
the European Union based on earlier trial 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 CSU
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 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 the Dupixent phase 3 CSU program
(LIBERTY-CUPID)
The LIBERTY-CUPID Phase 3 study program evaluating Dupixent for CSU
consists of Study A, Study B, and Study C.
Study C was a randomized, double-blind,
placebo-controlled clinical study that evaluated the efficacy and
safety of Dupixent as an add-on to standard-of-care antihistamines
compared to antihistamines alone in 151 patients aged six years and
older with CSU who remained symptomatic despite antihistamine use
and were not previously treated with omalizumab (i.e.,
biologic-naïve). The primary endpoint assessed the change from
baseline in itch at 24 weeks (measured by the weekly itch severity
score [ISS7], 0-21 scale). Secondary endpoints at 24 weeks,
measured by the weekly urticaria activity score (UAS7) included the
change from baseline in itch and hives (UAS7, 0-42 scale),
proportion of patients achieving well-controlled disease status
(UAS7 ≤6), and complete response (UAS7=0).
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,
chronic spontaneous urticaria, and chronic obstructive pulmonary
disease in different age populations. More than 1,000,000 patients
are 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
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and inflammatory diseases, cancer, cardiovascular and metabolic
diseases, neurological diseases, hematologic conditions, infectious
diseases, and rare diseases.
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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
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For more information, please visit
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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
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practice of medicine by working to turn the impossible into the
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Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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