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FDA Accepts Dupixent® (dupilumab) for Priority Review in Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis

FDA Accepts Dupixent® (dupilumab) for Priority Review in Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis

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TARRYTOWN, N.Y. and PARIS , Feb. 10, 2022 /PRNewswire/ — If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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