Sanofi Receives FDA Approval for Amlitelimab in Moderate-to-Severe Atopic Dermatitis

Sanofi today announced that the FDA has approved amlitelimab for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical therapies. This marks the first anti-OX40L antibody approved for atopic dermatitis. In the Phase 3 SOLO trial, amlitelimab demonstrated significant improvements in skin clearance and itch reduction, with durable responses observed after treatment discontinuation. Amlitelimab blocks OX40L signaling, a key driver of T-cell-mediated inflammation in atopic dermatitis.