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FDA Accepts Dupixent® (dupilumab) for Review in Children with Moderate-to-severe Asthma
TARRYTOWN, N.Y. and PARIS, March 4, 2021 /PRNewswire/ -- Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y. and PARIS, March 4, 2021 /PRNewswire/ -- \nSubmission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial\nDupixent has the potential to be a best-in-class treatment option in this younger population of children aged 6 to 11 \nAcceptance represents another milestone in the development of Dupixent in addressing diseases driven by type 2 inflammation \nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date for the FDA decision is October 21, 2021 and the European Union (EU) regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021.\nIn the U.S., there are approximately 75,000 children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, which can carry a significant burden for children and their families. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children can still experience coughing, wheezing, and difficulty breathing. They are also at risk for life-threatening severe asthma attacks that can lead to hospitalization and emergency room visits, and may require the use of systemic corticosteroids which carry significant risks when used long term. Uncontrolled moderate-to-severe asthma can impair lung function, and can interfere with day-to-day activities, like sleeping, attending school and playing sports.\nThe sBLA is supported by data that include pivotal Phase 3 results evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with type 2 inflammation, characterized by raised blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels. In the trial, Dupixent significantly reduced severe a...