Sanofi : CHMP recommends approval of Dupixent® (dupilumab) for moderate-to-severe atopic dermatitis in adolescents
June 28 2019 - 7:00AM
CHMP recommends approval of Dupixent® (dupilumab) for
moderate-to-severe atopic dermatitis in adolescents
PARIS AND TARRYTOWN, NY – June 27,
2019 - The European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion for Dupixent® (dupilumab) recommending extending its
approval in the European Union (EU) to also include adolescents 12
to 17 years of age with moderate-to-severe atopic dermatitis who
are candidates for systemic therapy.
If approved, Dupixent would be the first
biologic medicine approved in the EU to treat these patients. The
positive CHMP opinion is based on clinical data from the LIBERTY AD
program, including a pivotal Phase 3 trial and an open-label
extension trial evaluating the efficacy and safety of Dupixent in
adolescents with uncontrolled moderate-to-severe atopic dermatitis.
A final decision on the Dupixent application by the European
Commission (EC) is expected in the coming months.
Dupixent is a fully-human monoclonal antibody
that inhibits the signaling of interleukin-4 (IL-4) and
interleukin-13 (IL-13), two proteins that play a central role in
type 2 inflammation. Data from Dupixent clinical trials have shown
that inhibiting IL-4 and IL-13 helps address the type 2
inflammation that plays a major role in atopic dermatitis, asthma
and chronic rhinosinusitis with nasal polyposis (CRSwNP).
About Moderate-to-Severe Atopic
DermatitisAtopic dermatitis, the most common form of
eczema, is a chronic inflammatory disease. In its
moderate-to-severe form it is characterized by rashes that can
potentially cover much of the body, and can include intense,
persistent itching, skin lesions and skin dryness, cracking,
redness, crusting and oozing. Itch is one of the most burdensome
symptoms for patients and can be debilitating. Despite
standard-of-care therapy, there continues to be an unmet need for
many adolescents with moderate-to-severe atopic dermatitis who
often have uncontrolled, persistent symptoms.
About DupixentDupixent is being
developed jointly by Sanofi and Regeneron as part of a global
collaboration agreement. Dupixent is currently approved in the EU
for use in adults with moderate-to-severe atopic dermatitis who are
candidates for systemic therapy. It is also approved in the EU for
adults and adolescents 12 years and older as an add-on maintenance
treatment for severe asthma with type 2 inflammation characterized
by raised blood eosinophils and/or raised fractional exhaled nitric
oxide (FeNO), who are inadequately controlled with high dose
inhaled corticosteroid (ICS) plus another medicinal product for
maintenance treatment.
Outside of the EU, Dupixent is approved for use
in specific patients with moderate-to-severe atopic dermatitis and
certain patients with asthma in a number of other countries around
the world, including the U.S. and Japan. Dupixent is also approved
in the U.S. for use with other medicines to treat CRSwNP in adults
whose disease is not controlled and is currently under regulatory
review for patients with CRSwNP in the EU.
About the Dupilumab Development
ProgramIn addition to the currently approved indications,
Regeneron and Sanofi are also studying dupilumab in a broad range
of clinical development programs for diseases driven by allergic
and other type 2 inflammation including pediatric asthma and atopic
dermatitis (6 to 11 years of age, Phase 3), pediatric atopic
dermatitis (6 months to 5 years of age, Phase 2/3), eosinophilic
esophagitis (Phase 3), chronic obstructive pulmonary disease (Phase
3) and food and environmental allergies (Phase 2). Dupilumab is
also being studied in combination with REGN3500 (SAR440340), which
targets IL-33. These potential uses are investigational and the
safety and efficacy have not been 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 30 years by physician-scientists, our unique
ability to repeatedly and consistently translate science into
medicine has led to seven FDA-approved treatments and numerous
product candidates in development, all of which were homegrown in
our laboratories. Our medicines and pipeline are designed to help
patients with eye disease, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neuromuscular
diseases, infectious diseases and rare diseases.
Regeneron is accelerating and improving the
traditional drug development process through our proprietary
VelociSuite® technologies, such as VelocImmune® which produces
optimized fully-human antibodies, and 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 Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
Sanofi Media Relations
ContactAshleigh KossTel: +1 (908)
981-8745Ashleigh.Koss@sanofi.com Regeneron
Media RelationsSharon ChenTel: +1 (914)
847-5018Sharon.Chen@regeneron.com |
Sanofi
Investor Relations Contact George Grofik Tel.: +33 (0)1 53
77 45 45 ir@sanofi.com Regeneron Investor
RelationsJustin HolkoTel: +1 (914)
847-7786Justin.Holko@regeneron.com |
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