GlobeNewswire Inc | Oct 16, 2020 08:00AM EDT

October 16, 2020

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. Weare a global biopharmaceutical company focused on huan health. We preventillness with vaccines, provide innovative treatments to fight pain and easesuffering. We stand by the few who suffer from rare diseases and the millionswith long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transformingscientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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