FDA Expands Approval of Incyte’s Opzelura Topical Drug for Vitiligo

The FDA has expanded its approval of Incyte’s Opzelura (ruxolitinib) topical cream to include adult and pediatric patients 12 years and older with nonsegmental vitiligo, a chronic autoimmune disease characterized by loss of skin pigmentation.

Opzelura, a Janus kinase inhibitor topical drug, is the only FDA-approved treatment for repigmentation in patients with vitiligo.

The agency first approved the drug in September 2021 for the topical short-term and non-continuous chronic treatment of patients with mild-to-moderate atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

The expanded agency approval was based on positive results from two phase 3 trials in which treated patients saw significant improvements in facial and body pigmentation.