The FDA granted Incyte, a Wilmington, Del.-based pharmaceutical company, the first approval for a vitiligo treatment after finding positive results in its phase 3 trials July 18.
Vitiligo is a chronic autoimmune disease that presents as depigmenting the skin. It affects more than 1.5 million people in the U.S., according to an Incyte press release.
After 52 weeks, phase 3 trials for topical cream Opzelura showed improvements from the baseline in the facial Vitiligo Area Sourcing Index among 50 percent of the study participants.
Opzelura, a JAK inhibitor, is approved for ages 12 and up for nonsegmental vitiligo and mild to moderate eczema.