FDA Approves Dupixent for Pediatric Atopic Dermatitis

FDA has approved a Sanofi BLA for Dupixent (dupilumab) for children aged six 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. Dupixent is a monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, and is not an immunosuppressant, according to the company. Data have shown that IL-4 and IL-13 are key drivers of the Type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis, it says.

Approval is based on data from pivotal Phase 3 studies of Dupixent combined with topical corticosteroids (TCS) compared to TCS alone in children with severe atopic dermatitis. In the studies, children treated with Dupixent and TCS saw significant improvements in overall disease severity, skin clearance and itch, the company says.