FDA Approves Dupixent for Children with Asthma

The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Developed by Regeneron Pharmaceuticals and Sanofi, Dupixent is the only biologic to improve lung function in children 6 to 11 years old.

George D. Yancopoulos, M.D., Ph.D.

“Despite available treatments, moderate-to-severe asthma can severely impact children's developing airways, causing sleepless nights, persistent coughing and wheezing, and potentially life-threatening exacerbations that require the use of systemic steroids that can negatively affect growth,” George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, said in a statement.

The FDA approval is based on data from a phase 3 trial that evaluated the efficacy and safety of Dupixent combined with standard-of-care asthma therapy in children with uncontrolled moderate-to-severe asthma.

Among patients who had high levels of eosinophils, those who added Dupixent (100 mg or 200 mg every two weeks) to standard-of-care experienced a 65% average reduction of severe asthma attacks over one year compared with placebo. Patients also had improved asthma control at 24 weeks, with 81% of patients reporting a clinically meaningful improvement in disease symptoms compared with 64% of placebo patients.

Dupixent is dosed based on weight (100 mg every two weeks or 300 mg every four weeks for children ≥15 to <30 kg and 200 mg every two weeks for children ≥30 kg) and is supplied as a pre-filled syringe. It is also available as a pre-filled pen for adolescents (12 to 17 years) and adults at 200 mg and 300 mg doses.

In the United States, Dupixent is approved as an add-on maintenance treatment of patients aged 6 years and older with moderate-to-severe asthma; 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 in adults whose disease.