CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis
16 Outubro 2020 - 9:00AM
CHMP recommends approval of Dupixent® (dupilumab) for children aged
6 to 11 years with severe atopic dermatitis
CHMP recommends approval of Dupixent® (dupilumab) for
children aged 6 to 11 years with severe atopic
dermatitis
- Recommendation based on pivotal trial that showed Dupixent plus
topical corticosteroids (TCS) significantly improved measures of
overall disease severity, skin clearance, itch and health-related
quality of life measures, compared to TCS alone
- Data further reinforce the well-established safety profile of
Dupixent in adult and adolescent atopic dermatitis patients
- Dupixent would be the first biologic medicine available in the
EU to treat this patient group and remains the only biologic
medicine approved in moderate-to-severe atopic dermatitis for
adolescents and adults
PARIS and TARRYTOWN, NY
– October 16, 2020 – The European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) has
adopted a positive opinion for Dupixent® (dupilumab), recommending
to extend the approval in the European Union (EU) to include
children aged 6 to 11 years with severe atopic dermatitis who are
candidates for systemic therapy.
Dupixent is the first and only biologic approved for the
treatment of uncontrolled moderate-to-severe atopic dermatitis for
ages 12+ in the EU and ages 6+ in the U.S.
Dupixent is also approved in the EU for certain
patients with severe asthma and severe chronic rhinosinusitis with
nasal polyps, two other type 2 inflammatory diseases.
The European Commission is expected to announce
a final decision on the Dupixent application in the coming months.
The positive CHMP opinion is supported by data that include pivotal
Phase 3 results on the efficacy and safety of Dupixent combined
with TCS in children aged 6 to 11 years with severe atopic
dermatitis that is uncontrolled on topical prescription therapies.
In the trial, children treated with Dupixent and TCS experienced
significantly improved measures of overall disease severity (Eczema
Area and Severity Index), skin clearance, itch and health-related
quality of life measures, compared to TCS alone. Adverse events
more commonly observed with Dupixent included conjunctivitis,
nasopharyngitis and injection site reactions. These data are
consistent with the well-established efficacy and safety profile of
Dupixent observed across adult and adolescent atopic dermatitis
trials. The use of Dupixent in children aged 6 to 11 years is
investigational and its efficacy and safety has not yet been fully
evaluated in the EU.
Atopic dermatitis is a chronic inflammatory
disease of the skin that can be debilitating. The current standard
of care for children with severe atopic dermatitis in Europe is
limited to TCS leaving those with poorly controlled disease to cope
with intense, unrelenting itch and skin lesions that cover much of
the body resulting in skin cracking, redness or darkening, crusting
and oozing. In addition, uncontrolled severe atopic dermatitis can
have a significant emotional and psychosocial impact causing sleep
disturbance, symptoms of anxiety and depression, and feelings of
isolation for children and their families.
Dupixent is a fully-human monoclonal antibody
that inhibits the signaling of the interleukin-4 (IL-4) and
interleukin-13 (IL-13) proteins, and is not an immunosuppressant.
Data from Dupixent clinical trials have shown that IL-4 and IL-13
are key drivers of the type 2 inflammation that plays a major role
in atopic dermatitis, asthma and CRSwNP. Dupixent is currently
approved in more than 60 countries, and more than 170,000 patients
have been treated globally.
About
Dupixent
Dupixent is currently approved in the EU for use
in adults and adolescents 12 years and older 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. Dupixent is also approved in the EU for adults with
severe CRSwNP for whom therapy with systemic corticosteroids and/or
surgery do not provide adequate disease control.
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. and Japan to treat certain adults with severe
CRSwNP.
Dupilumab Development
Program
To date, dupilumab has been studied in more than
10,000 patients ages 6 and up across 50 clinical trials in various
chronic diseases driven by type 2 inflammation.
In addition to the currently approved
indications, Sanofi and Regeneron 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
(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), bullous
pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic
spontaneous urticaria (Phase 3), and food and environmental
allergies (Phase 2). These potential uses are investigational, and
the safety and efficacy have not been evaluated by any regulatory
authority. Dupilumab is being jointly developed by Sanofi and
Regeneron under a global collaboration agreement.
About RegeneronRegeneron
(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 eight 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 diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, pain, 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 Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on huan 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 Contact
Sally BainTel.: +1 (781) 264 1091Sally.Bain@sanofi.com
Regeneron
Media Relations ContactSharon ChenTel.: +1 914 847
1546Sharon.Chen@regeneron.com |
Sanofi
Investor Relations – Contacts ParisEva
Schaefer-JansenArnaud DelepineYvonne
Naughton Sanofi Investor Relations –
Contacts North AmericaFelix LauscherFara BerkowitzSuzanne
Greco Sanofi IR main
line:Tel.: +33 (0)1 53 77 45
45ir@sanofi.comhttps://www.sanofi.com/en/investors/contact Regeneron
Investor Relations ContactMark HudsonTel.: +1 (914) 847
3482Mark.Hudson@regeneron.com |
|
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