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Dupixent® (dupilumab) Approved by European Commission as First and Only Biologic Medicine for Children Aged 6 to 11 Years with Severe Atopic Dermatitis
TARRYTOWN, N.Y. and PARIS, Nov. 30, 2020 /PRNewswire/ -- Pivotal trial showed more than four times as many children achieved itch reduction and more than
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, Nov. 30, 2020 /PRNewswire/ --\nPivotal trial showed more than four times as many children achieved itch reduction and more than three times as many children achieved clear or almost clear skin with Dupixent plus topical corticosteroids (TCS) compared to TCS alone\nNearly three in four children achieved a 75% improvement in disease extent and severity, with an average improvement of approximately 80%\nApproximately 80% of children experienced clinically meaningful improvements in a composite of health-related quality of life measures that include sleep, school, emotional well-being and relationships\nExpanded approval of Dupixent for these children reinforces well-established, long-term safety profile \nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has extended the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. Dupixent is the only systemic medicine approved in the EU to treat these patients.\n\"As the parent of a child with atopic dermatitis, and someone who works with families impacted by this condition daily, I've seen first-hand the enormous physical and mental health burden of this disease, and the toll it can take on the entire family,\" said Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER). \"Young children with severe atopic dermatitis currently have few treatment choices and significant unmet needs. We welcome the addition of new medicines for these underserved patients.\" \nAtopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating, and severe disease can significantly impact many aspects of life for both children and their families. The current standard of care for children with severe atopic dermatitis in Europe is limited to topical treatments, leaving those with poorly-controlled disease to cope with intense, unrelenting itch and skin lesions that can cover much of the body, resulting in skin cracking, redness or darkening, crusting and oozing. In addition, uncontrolled severe atopic dermatitis can have a substantial emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression a...