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The FDA for non-segmental vitiligo in adults and children 12 years and older, making it the only FDA-approved treatment for repigmentation in vitiligo and the only topical formulation of a Janus kinase (JAK) inhibitor, Incyte announced on Monday.

Ruxolitinib cream initially received FDA approval for mild or moderate atopic dermatitis not adequately controlled by other prescription topical therapies in September 2021.

Vitiligo is a chronic autoimmune disease distinguished by depigmentation of skin that results from the loss of melanocytes. Overactivity of the JAK signaling pathway is thought to lead to inflammation involved in the pathogenesis and progression of vitiligo. More than 1.5 million people are diagnosed with vitiligo in the U.S., with about 85% having non-segmental vitiligo.

"Vitiligo is an immune-mediated disease that can be unpredictable, making it particularly difficult to treat," said David Rosmarin, MD, of the department of dermatology at Tufts Medical Center in Boston, in a statement from Incyte. "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 non-segmental vitiligo who are interested in potentially reversing the depigmentation caused by their disease."

Support for the vitiligo indication came from two 52-week, phase III, randomized, placebo-controlled trials that showed that significantly more patients with vitiligo met the endpoints of ≥75% and ≥90% improvement in vitiligo status from baseline. Patients who switched to ruxolitinib cream after initial randomization to placebo subsequently achieved similar rates of improvement as patients who started treatment with the JAK inhibitor.

The most common adverse reactions associated with ruxolitinib cream in the clinical trials included application-site acne and pruritus, nasopharyngitis, headache, urinary tract infection, application-site erythema, and pyrexia.

Labeling for ruxolitinib cream includes a boxed warning about a risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

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