US FDA Approves Ruxolitinib (Opzelura) to Treat Nonsegmental Vitiligo


The US Food and Drug Administration (FDA) has approved Incyte’s Ruxolitinib (Opzelura) cream 1.5 percent for the topical treatment of nonsegmental vitiligo in pediatric and adult patients above 12 years of age. The Opzelura is the first and only treatment approved by US FDA for repigmentation in patients with vitiligo, and it is the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States.

Vitiligo is a chronic autoimmune disease, which is characterized by the depigmentation of skin. Herve Hoppenot, chief executive officer of Incyte, said with the US FDA approval of Opzelura is nonsegmental vitiligo, and the company has once again delivered a treatment to patients with high unmet medical need who does not have any approved therapies.

He said they are very proud of scientists of Incyte and development teams that have made this approval possible, and they are pleased that eligible vitiligo patients will now have a choice to address repigmentation.

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In patients with nonsegemnatl vitiligo, the treatment is approved for continuous topical use two times a day to the affected areas of up to 10 percent surface area of the body. The patient response might require treatment with Opzelura for over 24 weeks.

The approval of US FDA is based on the data from the pivotal Phase 3 TRuE-V clinical trial program, evaluating the safety and efficacy of the treatment in over 600 people with nonsegmental vitiligo.