The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application for dupilumab as an add-on treatment for children 6 to 11 years of age with uncontrolled moderate to severe asthma.
The submission was based on data from the double-blind, placebo-controlled VOYAGE trial (ClinicalTrials.gov: NCT02948959), which included 408 pediatric patients aged 6 to 11 years with uncontrolled persistent asthma. Patients were randomly assigned to receive subcutaneous injections of dupilumab 100mg or 200mg every 2 weeks based on body weight, or placebo, in addition to standard of care maintenance.
Results showed that over 52 weeks of treatment, dupilumab significantly reduced severe asthma attacks by 65% in patients with elevated baseline blood eosinophils (P <.0001) and by 59% in those with markers of type 2 inflammation (P <.0001), compared with placebo. Additionally, treatment with dupilumab was associated with significant improvement in lung function, which was observed as early as 2 weeks and sustained for up to 52 weeks. The safety profile of dupilumab was found to be consistent with that observed in patients aged 12 years and older with moderate to severe asthma.
Dupilumab, an interleukin-4 receptor alpha antagonist, is marketed under the trade name Dupixent (Regeneron and Sanofi). It is currently FDA-approved as an add-on maintenance treatment in patients with moderate to severe asthma 12 years of age and older with an eosinophilic phenotype or with oral corticosteroid dependent asthma.
A Prescription Drug User Fee Act (PDUFA) date of October 21, 2021 has been set for the FDA’s decision on expanded approval for asthma in children 6 to 11 years old.
FDA accepts Dupixent® (dupilumab) for review in children with moderate to severe asthma. [press release]. Tarrytown, NY and Paris, France: Regeneron and Sanofi; March 4, 2021.