FDA accepts Dupixent for review in children with moderate-to-severe asthma
The U.S. Food and Drug Administration (FDA) has accepted for review a 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.
The U.S. Food and Drug Administration (FDA) is reviewing a supplemental application for Dupixent® (dupilumab) to treat children aged 6 to 11 years with moderate-to-severe asthma as an add-on therapy. This marks a potential expansion of the treatment for a younger pediatric population.
The application is supported by Phase 3 clinical trial data that demonstrated Dupixent significantly reduced severe asthma attacks and improved lung function in participants. Dupixent is a fully human monoclonal antibody that targets key signaling pathways of type 2 inflammation.
In the U.S., approximately 75,000 children aged 6 to 11 years experience uncontrolled moderate-to-severe asthma. This condition can significantly impact a child's quality of life, leading to persistent symptoms and a risk of severe, potentially life-threatening asthma attacks that may require hospitalization.
Dupixent is currently approved in the U.S. for patients aged 12 years and older with moderate-to-severe asthma that is not controlled with their current medications or requires oral corticosteroid dependency. A regulatory submission in the European Union for this younger age group is planned for the first quarter of 2021.