FDA Grants Priority Review for Sanofi and Regeneron's Dupixent

The FDA granted Sanofi and Regeneron priority review for Dupixent (dupilumab) 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 supplemental BLA was based on the results of a phase 3 clinical trial, in which children treated with Dupixent and topical corticoid steroids (TCS) experienced significant improvement in overall disease severity, skin clearing, itching and health-related quality of life, compared to steroids alone.

The FDA granted Dupixent a breakthrough therapy designation in 2016 for the treatment of severe atopic dermatitis in children 6 months to 11 years of age not well controlled on topical prescription medications. If approved, it will be the first biologic available for these children.