Incyte nabs second approval with JAK inhibitor cream for vitiligo
Following a three-month delay, the FDA has approved Incyte’s JAK inhibitor Opzelura for a second indication: vitiligo.
With the new approval, Opzelura becomes the first repigmentation cream approved for vitiligo, an autoimmune disease that causes patches of lost skin pigmentation and impacts millions — estimates for the US hover around 1% of the population, according to one study.
The approval comes on the back of two Phase III trials that enrolled around 600 patients over the age of 12. After 24 weeks, almost one third of patients met the primary endpoint — at least a 75% improvement in their vitiligo area score — compared to 8-13% of patients treated with a placebo cream. In an extended trial to one year, that figure grew to about half the patients in the study.
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