According to a press release by Incyte, The U.S. Food and Drug Administration has granted approval for a topical treatment for vitiligo in patients 12 and older.
The Delaware-based pharmaceutical company announced on Monday 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.
The U.S. Department of Health and Human Services defines vitiligo as a skin disorder that causes areas of a person’s skin to lose color. 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.
Incyte CEO, Hervé Hoppenot, said in the release:
“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. 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.”
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.
“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.”