Dupixent® (dupilumab) late-breaking Phase 3 data at EADV 2022
showed significant improvements in signs and symptoms of prurigo
nodularis
- Nearly three times as many Dupixent
patients experienced clinically meaningful reductions in itch and
skin lesions at 24 weeks compared to placebo
- There are currently no approved
medicines specifically indicated to treat prurigo nodularis;
regulatory submissions for Dupixent are under Priority Review in
the U.S. and under review in the European Union
- 22 Dupixent abstracts are being
presented at the European Academy of Dermatology and Venereology
(EADV) 2022 Congress across four dermatological diseases with
underlying type 2 inflammation
Paris and Tarrytown, N.Y.
September 8,
2022. Detailed positive results from the Phase 3 PRIME
trial evaluating Dupixent® (dupilumab) in adults with uncontrolled
prurigo nodularis were presented today in a late-breaking session
at the European Academy of Dermatology and Venereology (EADV) 2022
Congress. These data from one of two pivotal trials in prurigo
nodularis show Dupixent significantly reduced itch and skin lesions
at 24 weeks.
In total, 22 scientific abstracts are being
presented at the EADV 2022 Congress discussing Dupixent in atopic
dermatitis in patients as young as six months, and its
investigational use in chronic spontaneous urticaria and bullous
pemphigoid, in addition to prurigo nodularis.
Gil Yosipovitch,
M.D.Professor of Dermatology, Miller School of Medicine,
University of Miami, Director of the Miami Itch Center, and
principal investigator of the trial“These positive results from the
second of two dupilumab Phase 3 trials in prurigo nodularis confirm
inhibiting IL-4 and IL-13 can significantly reduce the unrelenting
itch and extensive severe skin lesions that often impair patient
quality of life. In my practice, relieving itch and clearing skin
are often the top priorities for my patients across a range of
chronic skin diseases. These data demonstrate dupilumab has the
potential to address and manage these debilitating symptoms in
another chronic skin disease with underlying type 2
inflammation.”
The late-breaking data presented at the EADV
2022 Congress are from the randomized, placebo-controlled Phase 3
PRIME trial, which met its primary and key secondary endpoints. At
24 weeks, among patients treated with Dupixent in the trial:
- More than three times as many (60%)
experienced a clinically meaningful reduction in itch from
baseline, the primary endpoint, compared to placebo patients (18%;
p<0.0001).
- Nearly three times as many (48%)
achieved clear or almost clear skin, a key secondary endpoint,
compared to placebo patients (18%; p=0.0004).
The safety results of the trial were generally
consistent with the known safety profile of Dupixent in its
approved dermatological indication. For the 24-week treatment
period, overall rates of adverse events (AEs) were 71% for Dupixent
and 63% for placebo. AEs most commonly observed with Dupixent (≥5%)
included nasopharyngitis (5% Dupixent, 4% placebo) and headache (5%
Dupixent, 5% placebo). The rate of treatment discontinuation due to
AEs prior to week 24 was 0% for Dupixent compared to 4% for
placebo. A numerically lower rate of skin infections was observed
with Dupixent (4% Dupixent, 9% placebo).
Results from this and an earlier Phase 3 trial,
PRIME2, will form the basis of regulatory submissions around the
world for Dupixent in prurigo nodularis this year. Regulatory
submissions are already under review by the European Commission and
the U.S. Food and Drug Administration, with the FDA granting
Priority Review in May 2022 and a target action date of September
30, 2022.
The potential uses of Dupilumab in prurigo
nodularis, chronic spontaneous urticaria and bullous pemphigoid are
currently under clinical development, and the safety and efficacy
have not been fully evaluated by any regulatory authority.
About Prurigo
NodularisPeople with prurigo nodularis experience intense,
persistent itch, with thick skin lesions (called nodules) that can
cover most of the body. Prurigo nodularis is often described as
painful with burning, stinging and tingling of the skin. The impact
of uncontrolled prurigo nodularis on quality of life is one of the
highest among inflammatory skin diseases due to the extreme itch
and comparable to other debilitating chronic diseases that can
negatively affect mental health, activities of daily living and
social interactions. High-potency topical steroids are commonly
prescribed but are associated with safety risks if used
long-term.
About the TrialPRIME, part of
the LIBERTY-PN PRIME clinical program, was a randomized, Phase 3,
double-blind, placebo-controlled trial that evaluated the efficacy
and safety of Dupixent in 151 adults with uncontrolled prurigo
nodularis. These included patients who were inadequately controlled
with topical prescription therapies or for whom those therapies
were not advisable. During the 24-week treatment period, patients
received Dupixent or placebo every two weeks with or without
topical treatments (low- or medium-dose topical corticosteroids or
topical calcineurin inhibitors were continued if patients were
using these treatments at randomization).
The primary endpoint evaluated the proportion of
patients with clinically meaningful improvement in itch at 24 weeks
(measured by a ≥4-point reduction in Worst-Itch Numeric Rating
Scale [WI-NRS] of 0-10). A key secondary endpoint was the
proportion of patients with clear or almost clear skin at 24 weeks
(measured by a score of 0 or 1 on the Investigator's Global
Assessment PN-Stage [IGA PN-S] 0-4 scale).
About DupixentDupixent 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 (EoE), as well as investigational
diseases such as prurigo nodularis.
Dupixent has received regulatory approvals
around the world for use in certain patients with atopic
dermatitis, asthma, CRSwNP or EoE in different age populations.
Dupixent is currently approved across these indications in the U.S.
and for one or more of these indications in more than 60 countries,
including in the European Union and Japan. More than 500,000
patients have been 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 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 prurigo nodularis, pediatric
eosinophilic esophagitis, hand and foot atopic dermatitis, chronic
inducible urticaria-cold, chronic spontaneous urticaria, chronic
pruritis of unknown origin, chronic obstructive pulmonary disease
with evidence of type 2 inflammation, chronic rhinosinusitis
without nasal polyposis, allergic fungal rhinosinusitis, allergic
bronchopulmonary aspergillosis 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 is a
leading biotechnology company that invents, develops and
commercializes 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 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,
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 more information, 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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