FDA accepts supplemental NDA for ruxolitinib in vitiligo
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Priority review of a supplemental new drug application for ruxolitinib for the treatment of vitiligo has been accepted by the FDA, Incyte announced in a press release.
A topical JAK inhibitor, Opzelura (ruxolitinib cream 1.5%) is currently approved for the treatment of mild to moderate atopic dermatitis in patients 12 years and older.
The sNDA for vitiligo treatment is based on data from the phase 3 TRuE-V clinical trial program, which found 29.9% of patients with vitiligo who were treated with ruxolitinib cream twice daily had an improvement of at least 75% in facial Vitiligo Area Scoring Index.
“Vitiligo is a chronic autoimmune disease that can have a profound impact on people’s lives,” Jim Lee, MD, PhD, group vice president, inflammation and autoimmunity, Incyte, said in the release. “Currently, there are no FDA-approved drug therapies for repigmentation in people with vitiligo. The FDA’s acceptance of our sNDA for ruxolitinib cream brings us one step closer to offering patients with vitiligo an additional treatment option.”
The FDA has set a Prescription Drug User Fee Act date of April 18, 2022.
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