FDA Extends Review of Opzelura for Skin Condition

The FDA has extended the review period for the supplemental new drug application (sNDA) for Incyte’s Opzelura (ruxolitinib cream) for the treatment of vitiligo. The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18, 2022. Previously, the date was April 18, 2022.

The FDA made this move to allow time to review additional data from the ongoing phase 3 studies submitted by Incyte in response to the FDA’s information request. The submission of the additional information has been determined by the FDA to constitute a major amendment to the sNDA, resulting in an extension of the PDUFA goal date.

“We are confident in the data from the TRuE-V clinical trial program, which supports our sNDA submission for ruxolitinib cream in vitiligo, and we look forward to bringing this innovative topical treatment to patients with vitiligo in the United States for whom there are no approved therapies that address repigmentation,” Steven Stein, M.D., chief medical officer, Incyte, said in a press release.

The FDA approved Opzelura in September 2021 as the first topical JAK inhibitor for the topical chronic treatment of mild-to-moderate atopic dermatitis in patients 12 years of age and older whose disease is not adequately controlled with topical prescription. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

The pivotal TRuE-V clinical trial program is evaluating the safety and efficacy of Opzelura in more than 600 adolescent and adult patients (age 12 and older) with vitiligo. In October 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement.

Vitiligo is a disease that causes the loss of skin color. Vitiligo occurs when cells that produce melanin die or stop functioning. Vitiligo affects people of all skin types, but it may be more noticeable in people with darker skin. The exact cause is unknown, but it is believed to be an autoimmune condition.

Worldwide prevalence estimates of vitiligo vary widely, ranging from 0.004% to 2.28%. One study suggests that about 40% of patients with vitiligo may be undiagnosed.