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# Incyte Review Extension on Opzelura Cream
- URL: https://www.fdaweb.com/incyte-review-extension-on-opzelura-cream/
- Published: 2022-03-14T12:00:00.000Z
- Updated: 2026-09-14T17:36:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151357

FDA has extened by three months its review of Incyte’s supplemental NDA for Opzelura (ruxolitinib) cream for treating vitiligo. The new user fee review action target date is 7/18\. The review extension is intended to provide FDA needed time to review additional data from ongoing Phase 3 studies submitted by Incyte in response to an agency information request. The new data submission was determined to be a major amendment. “The pivotal Phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2) is evaluating the safety and efficacy of ruxolitinib cream versus vehicle in more than 600 adolescent and adult patients (age 12 and older) with non-segmental vitiligo,” the company says.

Ruxolitinib cream (Opzelura) is described as a novel formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, which Incyte says is the only topical JAK inhibitor approved for use in the U.S. 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 whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.