Press release
Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream for the Treatment of Vitiligo
Opzelura is the first and only FDA-approved product for repigmentation in nonsegmental vitiligo Phase 3 data supporting the approval show treatment with
About this update from Incyte Corporation
[{"type":"text","content":"\n\nOpzelura is the first and only FDA-approved product for repigmentation in nonsegmental vitiligo\n\n\n\nPhase 3 data supporting the approval show treatment with Opzelura resulted in improvements in facial and total body repigmentation\n\n\n\nFifty-two week data demonstrate continued improvements in repigmentation with longer duration of treatment\n\n\n\nInvestor conference call and webcast scheduled for July 19, 2022, at 8:00 a.m. EDT\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is the first and only FDA-approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States. Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220718005819/en/Image of person with nonsegmental vitiligo (Photo: Business Wire)\n“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,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we're pleased that eligible vitiligo patients now have a choice to address repigmentation.”\n\nIn patients with non-segmental vitiligo, Opzelura is approved for continuous topical use twice daily to affected areas of up to 10% body surface area. Satisfactory patient response may require treatment with Opzelura for more than 24 weeks.\n\nThe FDA approval was based on data from the pivotal Phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), evaluating the safety and efficacy of Opzelura versus vehicle in more than 600 people with nonsegmental vitiligo, age 12 and older. In the studies, treatment with Opzelura resulted in significant improvements in VASI scores, which represent improvements in facial and total body repigmentation at Week 24 (primary analysis) compared to vehicle (non-medicated cream) and in a...