Dupixent Shows Consistent Efficacy and Safety Profile in Pediatric Asthma Patients

The Sanofi and Regeneron blockbuster drug Dupixent (dupilumab) has shown efficacy and safety in children age six to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation.

The results were from a phase 3 extension trial investigating Dupixent as a maintenance therapy when added to other asthma medications, said the companies.

The extension trial provided up to two years of data in total, the companies said. Dupixent demonstrated low rate of severe asthma attacks with an average of 0.118-0.124 events per year compared to 2.16-2.56 events per year at baseline.

The drug is FDA-approved as an add-on maintenance treatment of adult and pediatric patients age six years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The agency, however, has not approved Dupixent for the relief of acute bronchospasm or status asthmaticus.