Incyte Announces Long-Term Extension Data from Phase 3 TRuE-V Program Demonstrating Long-Term Safety and Durability of Response of Opzelura® (Ruxolitinib) Cream in Vitiligo

- Patients achieving a high level of facial repigmentation (≥F-VASI90) at Week 52 maintained durable response one year following withdrawal of treatment

- Continued treatment with Opzelura for up to two years resulted in sustained facial repigmentation and further improvements in facial and total body repigmentation

- Data featured as oral presentations in two late-breaking abstract sessions at the 2023 American Academy of Dermatology (AAD) Annual Meeting

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced new 104-week results from the pivotal Phase 3 TRuE-V clinical trial program evaluating Opzelura® (ruxolitinib) cream 1.5% in patients 12 years of age and older with nonsegmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin. These data were presented today in two late-breaking oral presentations (Session: S025 – Late Breaking Research: Session 1) at the 2023 American Academy of Dermatology (AAD) Annual Meeting, held from March 17-21 in New Orleans.

The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.

“The results presented today at AAD are significant because they provide important long-term efficacy and safety data for nonsegmental vitiligo patients treated with Opzelura,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “The data, which showed improvements in both facial and total body repigmentation with continued treatment, further our understanding of the long-term benefits of Opzelura as a safe and meaningful pharmacologic treatment option for vitiligo patients.”

The LTE evaluated TRuE-V1 and TRuE-V2 study participants from Weeks 52 to 104 in two separate cohorts based on patients who achieved a complete or almost complete response by Week 52. In the cohort of patients who achieved complete or almost complete facial repigmentation (≥F-VASI90, Cohort A), patients were randomized in a double-blind fashion to receive Opzelura twice daily (BID) or vehicle (i.e., Opzelura withdrawal) through Week 104 to evaluate time to relapse (defined as