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FDA Accepts Dupixent (dupilumab) for Review in Children with Moderate-to-severe Asthma

March 4, 2021

Via: BioSpace

Regeneron 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.

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