Incyte grabs first and only FDA approval for topical vitiligo treatment

July 20, 2022

Incyte announced this week that the FDA has approved its JAK inhibitor cream, Opzelura, for the topical treatment of nonsegmental vitiligo in patients aged 12 and older. The approval makes the drug the first and only FDA-approved product for repigmentation in patients with the condition.

Characterized by depigmentation of the skin, vitiligo is a chronic autoimmune disease that affects between 0.5 percent and 1 percent of the population worldwide according to the National Institutes of Health. While a genetic component is known to be involved, over-activity of the JAK signaling pathway is also believed to drive inflammation involved in the progression of vitiligo. Nonsegmental vitiligo is the most common, which causes symmetric white patches on both sides of the body.

The green light was based on data from a phase 3 TRuE-V clinical trial program, where the drug proved to significantly improve facial and total body repigmentation in patients. The study included 600 people with nonsegmental vitiligo, and at the 24-week mark, 30% of those patients had achieved better vitiligo-measuring index scores.

Last year, Opzelura received FDA approval for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older. A few months later, the company faced some manufacturing hiccups and received three product complaints related to the cream's texture. Incyte followed up with a press release, stating that it had informed the FDA and conducting a thorough root cause analysis across all batches. 

With the added indication, Incyte is looking ahead. “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,” concluded Hervé Hoppenot, Chief Executive Officer at Incyte.