The Food and Drug Administration has approved dupilumab for children aged 6-11 years with moderate to severe atopic dermatitis, the manufacturers announced.
The new indication is for children “whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable,” Regeneron and Sanofi said in a press release, which points out that this is the first biologic approved for AD in this age group.
For children aged 6-11, the two available dupilumab (Dupixent) doses in prefilled syringes are given based on weight – 300 mg every 4 weeks for children between 15 to 29 kg and 200 mg every 2 weeks for children 30 to 59 kg – following an initial loading dose.
In phase 3 trials, children with severe AD who received dupilumab and topical corticosteroids improved significantly in overall disease severity, skin clearance, and itch, compared with those getting steroids alone. Eczema Area and Severity Index-75, for example, was reached by 75% of patients on either dupilumab dose, compared with 28% and 26% , respectively, for those receiving steroids alone every 4 and every 2 weeks, the statement said.
Over the 16-week treatment period, overall rates of adverse events were 65% for those getting dupilumab every 4 weeks and 61% for every 2 weeks – compared with steroids alone (72% and 75%, respectively), the statement said.
The fully human monoclonal antibody inhibits signaling of the interleukin-4 and interleukin-13 proteins and is already approved as an add-on maintenance treatment in children aged 12 years and older with moderate to severe asthma (eosinophilic phenotype or oral-corticosteroid dependent) and in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis, according to the prescribing information.