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

Amgen today announced that the FDA has approved Ebglyss (rocatinlimab) for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Rocatinlimab is an anti-OX40 monoclonal antibody that targets the OX40 pathway, a key driver of T-cell-mediated inflammation in atopic dermatitis. In the Phase 3 ROCKET program, rocatinlimab demonstrated significant improvements in IGA scores and EASI scores compared to placebo. The approval adds a new mechanism of action to the growing armamentarium of biologic treatments for atopic dermatitis.