The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent®; Regeneron and Sanofi) as an add-on maintenance treatment for children aged 6 to 11 years with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
The sBLA is supported by data from a phase 3 double-blind, placebo-controlled trial that evaluated the efficacy and safety of dupilumab in 367 patients aged 6 to 11 years with severe atopic dermatitis whose disease could not be adequately controlled with topical medications. Patients were randomized to receive 1 of 3 treatments for 16 weeks: dupilumab subcutaneous injection 300mg every 4 weeks (with an initial dose of 600mg); dupilumab 100mg (<30kg) or 200mg (≥30kg) every 2 weeks (with an initial dose of 200mg or 400mg, respectively); and placebo every 2 or 4 weeks. Each group also received background treatment with topical corticosteroids and moisturizers.
Results showed that a significantly greater proportion of patients treated with dupilumab achieved clear or almost clear skin at week 16, as measured by Investigator’s Global Assessment (IGA; primary end point) (33% for dupilumab every 4 weeks [P <.0001] and 30% for dupilumab every 2 weeks [P=.0004] vs 11% for placebo). In addition, results showed that 70% of patients who received dupilumab every 4 weeks and 67% of patients who received dupilumab every 2 weeks had a ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75), compared with 27% of the placebo group (both P<.0001).
With regard to safety, the most common adverse events reported were conjunctivitis, nasopharyngitis, and injection site reactions.
A Prescription Drug User Fee Act (PDUFA) target date of May 26, 2020 has been assigned to the application. If approved, dupilumab would be the first biologic treatment for atopic dermatitis available in the US for this patient population.
Dupixent®, an interleukin-4 receptor alpha antagonist, is currently approved for moderate to severe atopic dermatitis in patients ≥12 years old who are not adequately controlled with topical prescription therapies or when they are not advisable. It is also indicated for use as add-on maintenance treatment in patients with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma and as add-on maintenance treatment in patients with inadequately controlled chronic rhinosinusitis with nasal polyposis.