The U.S. Food and Drug Administration (FDA) on Thursday approved Incyte Corporation’s (NASDAQ:INCY) announced Opzelura (ruxolitinib) cream 1.5% for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised children two years of age and older whose disease is not well controlled with topical prescription therapies, or when those therapies are not recommended.
The FDA approval of the supplemental New Drug Application (sNDA) for Opzelura was based on data from the pivotal Phase 3 TRuE-AD3 trial.
