Amgen Receives FDA Approval for Rocatinlimab in Moderate-to-Severe Atopic Dermatitis

Amgen today announced that the FDA has approved rocatinlimab for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical therapies. In the Phase 3 ROCKET trial, rocatinlimab demonstrated significant improvements in skin clearance and itch reduction compared to placebo. Rocatinlimab is a fully human anti-OX40 monoclonal antibody that depletes OX40-expressing T cells. Notably, rocatinlimab showed durable responses even after treatment discontinuation, suggesting potential disease modification. This approval provides patients with a new biologic treatment option for AD.