CHMP recommends approval of Dupixent (dupilumab) for asthma indication
PARIS and TARRYTOWN, NY ?? 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 (IL4) 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-tosevere 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 FDAapproved 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
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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
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Tel.: +1 (908) 981-8745
Ashleigh.Koss@sanofi.com
Regeneron Media Relations Contact
Sharon Chen
Tel: +1 (914) 847-5018
Sharon.chen@regeneron.com
Investor Relations Contact
George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Regeneron Investor Relations Contact
Mark Hudson
Tel: +1 (914) 847-3482
Mark.Hudson@regeneron.com
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(dupilumab)
Injection; the impact of the opinion adopted by the European Medicine Agency?s Committee for Medicinal Products for Human
Use discussed in this news release on the European Commission?s decision regarding the Marketing Authorization Application
for Dupixent for use as an add-on maintenance treatment for adults and adolescents (12 years and older) who have severe
asthma with type 2 inflammation and who are inadequately controlled with medium-to-high dose inhaled corticosteroid plus
another medicinal product for maintenance treatment, and for the treatment of oral corticosteroid-dependent asthma regardless
of type 2 inflammatory biomarkers; the likelihood, timing, and scope of possible regulatory approval and commercial launch of
Regeneron's late-stage product candidates and new indications for marketed products, including possible regulatory approval of
Dupixent in the European Union discussed in this news release and possible regulatory approval of Dupixent in other
jurisdictions and indications (such as for the treatment of pediatric and adolescent atopic dermatitis, pediatric asthma, chronic
rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, food allergy (including peanut), chronic obstructive
pulmonary disease, and other potential indications (as well as in combination with REGN3500)); unforeseen safety issues
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complications or side effects in connection with the use of Regeneron?s product candidates in clinical trials; ongoing regulatory
obligations and oversight impacting Regeneron?s marketed products (such as Dupixent), research and clinical programs, and
business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities
which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron?s products and product
candidates, including without limitation Dupixent; the availability and extent of reimbursement of the Company?s products (such
as Dupixent) from third-party payers, including private payer healthcare and insurance programs, health maintenance
organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage
and reimbursement determinations by such payers and new policies and procedures adopted by such payers; uncertainty of
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other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating
to EYLEA?
(aflibercept) Injection, Dupixent, and Praluent?
(alirocumab) Injection, the ultimate outcome of any such litigation
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