CHMP Recommends Approval of Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Severe Atopic Dermatitis
October 16, 2020 at 07:59 AM EDT
TARRYTOWN, N.Y. and PARIS, Oct. 16, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that 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 people 12 years of age and older in the EU and 6 years of age and older in the U.S. Dupixent is also approved in the EU for certain patients with severe asthma and severe chronic rhinosinusitis with nasal polyps (CRSwNP), 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 topical corticosteroids (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 have 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.
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
In addition to the currently approved indications, Regeneron and Sanofi are also studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, 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 of dupilumab in these conditions have not been evaluated by any regulatory authority. Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
Dupilumab was invented using Regeneron's VelocImmune® technology that utilizes a proprietary genetically-engineered mouse platform endowed with a genetically-humanized immune system to produce optimized fully-human antibodies. VelocImmune technology has been used to create multiple antibodies including Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab) and Kevzara® (sarilumab), which are approved in multiple countries around the world. Regeneron previously used these technologies to rapidly develop a treatment for Zaire ebolavirus infection, which is approved by the FDA, and to create REGN-COV2, a potentially preventative and therapeutic investigational medicine for COVID-19 that was recently submitted to the FDA for an Emergency Use Authorization (EUA).
DUPIXENT is a prescription medicine used:
IMPORTANT SAFETY INFORMATION FOR U.S. PATIENTS
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis or CRSwNP, and also have asthma. Do not change or stop your corticosteroid medicine or other asthma medicine without talking to your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine or other asthma medicine to come back.
DUPIXENT can cause serious side effects, including:
The most common side effects by indications are as follows:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed. Your healthcare provider will tell you how much DUPIXENT to inject and how often to inject it. DUPIXENT is an injection given under the skin (subcutaneous injection). If your healthcare provider decides that you or a caregiver can give DUPIXENT injections, you or your caregiver should receive training on the right way to prepare and inject DUPIXENT. Do not try to inject DUPIXENT until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that DUPIXENT be administered by or under supervision of an adult. In children younger than 12 years of age, DUPIXENT should be given by a caregiver.
Please see full Prescribing Information including Patient Information.
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.
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