FDA accepts priority review of dupilumab for adolescent atopic dermatitis


The Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for dupilumab in patients aged 12-17 years with moderate to severe atopic dermatitis (AD) who have not been well controlled with topical therapies or who are unable to use topical therapies.

In a statement, dupilumab manufacturers Regeneron and Sanofi announced that the target action data for an FDA decision on dupilumab for adolescents is March 11, 2019. “Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate to severe atopic dermatitis,” the companies said in the statement.

The sBLA for dupilumab use in teens is based on data from a phase 3 study presented at the annual congress of European Academy of Dermatology and Venereology in September 2018. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo.

According to the companies, the most common adverse events included injection site reactions, oropharyngeal pain, and cold sores. Conjunctivitis has also been reported in some patients.

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, is currently approved for treating uncontrolled moderate to severe AD in adults and, more recently, as an add-on maintenance treatment in patients with moderate to severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid–dependent asthma.

The FDA granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications.

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