Sanofi: CHMP recommends approval of Dupixent® (dupilumab) for asthma indication
01 Marzo 2019 - 7:14AM
CHMP recommends approval of Dupixent® (dupilumab) for asthma
indication
PARIS and TARRYTOWN, NY - March 1, 2019 -
The European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) has adopted a positive opinion for
Dupixent® (dupilumab), recommending its approval in the European
Union for use in adults and adolescents 12 years and older as
add-on maintenance treatment for severe asthma with type 2
inflammation characterized by raised blood eosinophils and/or
raised FeNO who are inadequately controlled with high dose inhaled
corticosteroid plus another medicinal product for maintenance
treatment.
The positive CHMP opinion is based on clinical
data from 2,888 adults and adolescents who participated in three
pivotal trials from the global LIBERTY ASTHMA program, including
the Phase 3 QUEST and VENTURE trials. QUEST compared Dupixent vs.
placebo in asthma patients inadequately controlled on a medium or
high dose inhaled corticosteroid and a second controller
medication. VENTURE compared Dupixent vs. placebo in oral
corticosteroid dependent asthma patients. The European
Commission is expected to make a final decision on the application
for Dupixent in the coming months.
Dupixent is a human monoclonal antibody that
inhibits the signaling of interleukin-4 (IL-4) and interleukin-13
(IL-13), two key proteins that play a central role in type 2
inflammation that underlies specific types of asthma as well as
several other allergic diseases. This effect is
associated with the reduction of type 2 inflammatory biomarkers
including fractional exhaled nitric oxide (FeNO), immunoglobulin E
(IgE) and eotaxin-3 (CCL26).
Patients with severe asthma often have
uncontrolled, persistent symptoms despite standard-of-care therapy
that may make them suitable for treatment with a biologic therapy.
Symptoms of uncontrolled disease include coughing, wheezing and
difficulty breathing, and these patients are at risk of severe
asthma attacks that may require emergency room visits or
hospitalizations. Oral corticosteroids can provide relief for
severe, short-term symptoms; however, current asthma guidelines
suggest limiting their chronic use to the most severe patients due
to the potential for serious side effects.
Dupixent is being developed jointly by Sanofi
and Regeneron as part of a global collaboration agreement. In
October 2018, Dupixent was approved in the U.S. as an add-on
maintenance therapy in patients with moderate-to-severe asthma aged
12 years and older with an eosinophilic phenotype or with oral
corticosteroid-dependent asthma. Dupixent is not used to treat
sudden breathing problems. Dupixent is currently under regulatory
review for specific types of asthma in Japan.
Dupixent is currently approved in the European
Union for use in adults with moderate-to-severe atopic dermatitis
who are candidates for systemic therapy. Dupixent is also approved
for use in specific patients with moderate-to-severe atopic
dermatitis in a number of other countries around the world.
Dupilumab development program
Sanofi and Regeneron are also studying dupilumab
in a broad range of clinical development programs for diseases
driven by type 2 inflammation, including chronic rhinosinusitis
with nasal polyps (Phase 3 completed), pediatric (6 to 11 years of
age) atopic dermatitis (Phase 3), pediatric (6 months to 5 years of
age) atopic dermatitis (Phase 2/3), adolescent (12 to 17 years of
age) atopic dermatitis (Phase 3 completed), pediatric (6 to 11
years of age) asthma (Phase 3), eosinophilic esophagitis (Phase
2/3) and food and environmental allergies (Phase 2). A future trial
is planned for chronic obstructive pulmonary disease. Dupilumab is
also being studied in combination with REGN3500, 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 |
Media Relations Contact Ashleigh Koss Tel.: +1 (908)
981-8745 Ashleigh.Koss@sanofi.com Regeneron Media Relations
ContactSharon ChenTel: +1 (914)
847-5018Sharon.chen@regeneron.com |
Investor Relations
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Regeneron Investor Relations ContactMark HudsonTel: +1 (914)
847-3482Mark.Hudson@regeneron.com |
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