Press Release: FDA accepts Dupixent® (dupilumab) for priority
review in adults with prurigo nodularis
FDA accepts Dupixent® (dupilumab) for priority review in
adults with prurigo nodularis
- Dupixent would be the first and
only medicine specifically indicated to treat prurigo nodularis in
the U.S., if approved
- Acceptance marks
another important step in advancing Dupixent for a broad range of
diseases with underlying type 2 inflammation
Paris and Tarrytown, N.Y.
May 31, 2022. The U.S. Food and
Drug Administration (FDA) has accepted for priority review the
supplemental Biologics License Application (sBLA) for Dupixent®
(dupilumab) to treat adults with prurigo nodularis, a chronic
inflammatory skin disease that causes extreme itch and skin
lesions. The target action date for the FDA decision is September
30, 2022.
The sBLA is supported by data from two pivotal
Phase 3 trials evaluating the efficacy and safety of Dupixent in
patients 18 years and older with uncontrolled prurigo nodularis
(PRIME2 and PRIME). Both trials met the primary and key secondary
endpoints, showing Dupixent significantly improved disease signs
and symptoms compared to placebo, including reduction in itch and
skin lesions. The safety results from these trials were generally
consistent with the known safety profile of Dupixent in atopic
dermatitis. The adverse event more commonly observed with Dupixent
was conjunctivitis.
The FDA grants priority review to therapies that
have the potential to provide significant improvements in the
treatment, diagnosis or prevention of serious conditions.
Additional regulatory filings outside of the US are also planned in
2022. The potential use of Dupixent in prurigo nodularis is
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 is
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.
There are approximately 75,000 people in the U.S. who are unable to
control their disease with systemic therapy and are most in need of
a treatment option.
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 and eosinophilic esophagitis,
as well as investigational diseases such as prurigo nodularis.
Dupixent is approved for use in certain patients
with atopic dermatitis, asthma, chronic rhinosinusitis with nasal
polyposis and eosinophilic esophagitis in different age populations
in a number of countries around the world. Dupixent is currently
approved across these indications in the U.S. and for one or more
of these indications in the European Union, Japan and more than 60
countries. More than 400,000 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 in 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 Regeneron Regeneron (NASDAQ:
REGN) is a leading biotechnology company that invents
life-transforming medicines for people with serious diseases.
Founded and led for over 30 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 additional information about the company,
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
Sanofi Media RelationsSally
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