FDA Approves Dupilumab for Children Aged 6 to 11 With Moderate to Severe Asthma

Sold under the name Dupixent, dupilumab is a biologic that inhibits interleukin (IL)-4 and IL-13, which are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and eosinophilic esophagitis.

The FDA Wednesday approved dupilumab as an add-on maintenance treatment for pediatric patients aged 6 to 11 years with moderate to severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Sold under the name Dupixent, dupilumab is a biologic that inhibits interleukin (IL)-4 and IL-13, which are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and eosinophilic esophagitis.

The drug is already approved in patients aged 6 years and older with uncontrolled moderate to severe atopic dermatitis; and for use with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled.