Press release
Pivotal Phase 3 Data Showing Significant Improvements in Facial and Total Body Repigmentation with Ruxolitinib Cream (Opzelura™) in Vitiligo Published in New England Journal of Medicine
Data served as basis for recent FDA approval of ruxolitinib cream (Opzelura™) 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric
About this update from Incyte Corporation
[{"type":"text","content":"\nData served as basis for recent FDA approval of ruxolitinib cream (Opzelura™) 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older\n\nFifty-two week data from the Phase 3 TRuE-V clinical trial program demonstrate an increase in the proportion of patients achieving repigmentation with longer duration of ruxolitinib cream treatment1\n\nVitiligo is a chronic autoimmune disease characterized by depigmentation of skin\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that data from the pivotal Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream (Opzelura™) 1.5% in patients 12 years of age and older with nonsegmental vitiligo have been published in The New England Journal of Medicine (NEJM). In the trials (TRuE-V1 and TRuE-V2), application of ruxolitinib cream resulted in significant facial and total body repigmentation versus vehicle-control as shown by greater proportions of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI and T-VASI, respectively) endpoints at Week 24 vs. vehicle, with a higher proportion of patients responding at Week 521.\n\n“Incyte is committed to developing innovative medicines for people with immune-mediated dermatologic conditions, and the publication of the TRuE-V results in NEJM is the culmination of years of work to advance science in vitiligo where there were no approved pharmacologic treatments for repigmentation,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “These pivotal results demonstrate significant improvements in facial and total body repigmentation with ruxolitinib cream, and we are proud that these data served as the foundation for the recent approval of ruxolitinib cream as the first and only U.S. Food and Drug Administration (FDA)-approved treatment for repigmentation in nonsegmental vitiligo.”\n\nResults from the Phase 3 TRuE-V studies vehicle-controlled period (24 weeks) were previously announced, and Week 52 data were featured in an oral presentation at the late-breaking abstract session at the American Academy of Dermatology (AAD) Annual 2022 Meeting. Key findings from the studies include:\n\n\nResults at Week 24, which were consistent across both studies, showed that approximately 30% of patients treated with rux...