The FDA expanded the approved indications for dupilumab (Dupixent) injection to include add-on maintenance treatment of patients 6 to 11 years of age with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticoid-dependent asthma. Treatment with dupilumab was previously approved only for patients 12 years of age and older. Dupilumab is the only biologic medication the FDA has approved for children with oral corticosteroid-dependent asthma.
In a phase 3 trial that evaluated the efficacy and safety of dupilumab combined with standard-of-care asthma therapy in children with uncontrolled moderate-to-severe asthma, dupilumab substantially reduced the rate of severe asthma attacks: a 65% average reduction over 1 year compared with placebo and improved lung function as early as 2 weeks that was sustained for up to 52 weeks. The data also showed improved asthma control at 24 weeks, with 81% of patients reporting a clinically meaningful improvement based on disease symptoms and impact.
Dupilumab is a product of Regeneron and Sanofi. It is available as subcutaneous injection and is supplied as a prefilled syringe; a prefilled pen is available for adolescents and adults. Consult product labeling for detailed prescribing information.
