Press Release: Dupixent® (dupilumab) recommended for EU approval by
the CHMP for the treatment of prurigo nodularis
Dupixent® (dupilumab) recommended for EU approval by the CHMP
for the treatment of prurigo nodularis
- Recommendation is based on data
from two pivotal trials showing Dupixent significantly improved
itch, skin lesions and health-related quality of life in adults
with prurigo nodularis
- If approved, Dupixent would be the
first and only targeted medicine specifically indicated for prurigo
nodularis in the European Union
Paris and Tarrytown,
N.Y. November
11, 2022. The
European Medicines Agency’s Committee for Medicinal Products for
Human Use (CHMP) has adopted a positive opinion, recommending the
approval of Dupixent® (dupilumab) in the European Union (EU) to
treat adults with moderate-to-severe prurigo nodularis who are
candidates for systemic therapy. The European Commission is
expected to announce a final decision on the Dupixent application
in the coming months. In September 2022, Dupixent was approved by
the U.S. Food and Drug Administration for the treatment of adult
patients with prurigo nodularis.
Prurigo nodularis is a chronic, debilitating
skin disease with underlying type 2 inflammation and has one of the
highest impacts on a patient’s quality of life among inflammatory
skin diseases due to the extreme itch it causes. Those with prurigo
nodularis experience intense, persistent itch with thick skin
lesions (called nodules) that can cover most of the body. The
disease is often painful – with burning, stinging and tingling of
the skin – and 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.
The positive CHMP opinion is supported by data
from two Phase 3 trials, PRIME and PRIME2, showing Dupixent
significantly reduced itch (the primary endpoint) and skin lesions
compared to placebo. Dupixent also significantly improved
health-related quality of life while reducing measures of skin pain
and symptoms of anxiety/depression. The safety results of the trial
were generally consistent with the known safety profile of Dupixent
in its approved dermatology indication. Adverse events more
commonly observed with Dupixent compared to placebo included
conjunctivitis.
The use of Dupixent in adults with
moderate-to-severe prurigo nodularis is investigational in the EU
and is not yet approved.
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 and
chronic rhinosinusitis with nasal polyposis (CRSwNP), as well as
investigational diseases prurigo nodularis and eosinophilic
esophagitis (EoE) in the EU.
Dupixent has received regulatory approvals in
one or more countries around the world for use in certain patients
with atopic dermatitis, prurigo nodularis, 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
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 pediatric EoE, hand and foot
atopic dermatitis, chronic inducible urticaria-cold, chronic
spontaneous urticaria, chronic pruritus 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 Regeneron
Regeneron 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 nine FDA-approved treatments and numerous 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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