FDA Grants Approval to First Treatment for Vitiligo

The FDA approved Incyte’s Opzelura topical cream, known as ruxolitinib, to treat vitiligo in patients 12 and older

woman with vitiligo
Photo: Getty

The U.S. Food and Drug Administration has granted approval to a topical treatment for vitiligo in patients 12 and older, according to Incyte.

On Monday, the Delaware-based pharmaceutical company announced that its Opzelura cream, known as ruxolitinib, is the first FDA-approved treatment for repigmentation in patients with nonsegmental vitiligo, the most common form of the skin disorder.

Vitiligo is a skin disorder that causes areas of a person's skin to lose color, according to the U.S. Department of Health and Human Services. Between .5 and 1% of the global population lives with vitiligo, which tends to progress over time, according to the Department.

Though there is no cure for vitiligo, there are treatments that can help the skin tone appear more even.

"With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies," Hervé Hoppenot, Incyte CEO, said in a release. "We are proud of Incyte's scientists and development teams that have made this milestone possible, and we're pleased that eligible vitiligo patients now have a choice to address repigmentation."

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Man with vitiligo

Incyte said that its clinical trials for ruxolitinib found that 30% of patients using the cream regained 75% or more skin repigmentation on their face after 24 weeks and about 20% regained at least 50% or more repigmentation on their body.

Berardo Rivas, a 41-year-old man living with vitiligo for over 30 years, told ABC News that growing up with the skin disorder was "traumatizing," but he was thrilled after joining the clinical trial with Incyte. He revealed that he saw results after four months and more noticeable results after a year.

"My wife looked at me. She stared at me and she said, 'You know, you have pigment back on your eyes.' And I didn't believe her," Rivas told the outlet. "So I ran straight to the mirror. And I saw it ... I was just jumping with joy. It's like, oh, it's working. You know, thank God."

"Vitiligo is an immune-mediated disease that can be unpredictable, making it particularly difficult to treat," Dr. David Rosmarin, Vice Chair of Research and Education, Department of Dermatology at Tufts Medical Center, said in a release. "There have been no FDA-approved therapies available to date and the approval of Opzelura therefore marks a significant milestone. I welcome a medical treatment that helps my patients with nonsegmental vitiligo who are interested in potentially reversing the depigmentation caused by their disease."

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