FDA Approves Dupixent for Children Aged 6 to 11 with Asthma
The U.S. Food and Drug Administration (FDA) has expanded the approval of Dupixent to include children aged 6 to 11 years with moderate-to-severe asthma.
The U.S. Food and Drug Administration (FDA) has expanded its approval for Dupixent (dupilumab) to include children aged 6 to 11 years suffering from moderate-to-severe asthma. The medication is indicated as an add-on maintenance treatment for patients with an eosinophilic phenotype or those dependent on oral corticosteroids.
The expanded approval follows data from a Phase 3 trial demonstrating Dupixent's efficacy in improving lung function and reducing severe asthma exacerbations in children. This marks Dupixent as the only biologic medicine approved by the FDA for this pediatric age group.
Asthma is a common chronic condition in children, with an estimated 75,000 children aged 6 to 11 in the U.S. living with moderate-to-severe, uncontrolled disease. Many continue to experience symptoms and require repeated courses of systemic corticosteroids, which carry significant risks.
Developed by Sanofi and Regeneron, Dupixent targets underlying Type 2 inflammation and has a well-established safety profile across multiple conditions. This new approval provides a treatment option for younger children with specific types of moderate-to-severe asthma.