Full Press Release Details
CHMP recommends approval of Dupixent (dupilumab) for
children aged 6 to 11 years with severe asthma with type 2 inflammation
PARIS and TARRYTOWN, N.Y. January 31, 2022 - The
European Medicines Agency s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to extend the approval of Dupixent (dupilumab) in the
European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional
exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
The CHMP positive opinion is supported by Phase 3 data recently published in the New England
Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children
with uncontrolled moderate-to-severe asthma. The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12
years and older with uncontrolled moderate-to-severe asthma. Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions,
viral upper respiratory tract infections and eosinophilia. Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to11 years.
Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to
have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children may continue to experience
serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children s developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple
courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities, like sleeping, attending school
On October 20, 2021, Dupixent was approved by the FDA as an
add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic
phenotype or with oral corticosteroid-dependent asthma. The use of Dupixent in children aged 6 to 11 years with uncontrolled severe asthma is investigational in the EU and is not yet approved.
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. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a
major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is currently approved in Europe 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 FeNO, who are inadequately
controlled with high-dose ICS plus another medicinal product for maintenance treatment. It is also approved in the U.S., Japan and other countries around the world for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis as well as CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries
around the world, and more than 350,000 patients have been treated globally.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across 60
clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes including chronic obstructive pulmonary disease with evidence of type 2 inflammation
(Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold
(Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). 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.
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.
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 Media Relations Contact
Tel: +1 (781) 264-1091
Regeneron Media Relations Contact
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Investor Relations Contact North America
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without limitation Dupixent (dupilumab); the impact of the opinion adopted by the European Medicines Agency s Committee for Medicinal Products for Human Use discussed in this press
release on potential approval by the European Commission of Dupixent as an add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation who are inadequately
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litigation and other related proceedings relating to EYLEA (aflibercept) Injection, Dupixent, Praluent (alirocumab), and REGEN-COV (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations,