Incyte announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream (Opzelura™), a topical JAK inhibitor, in adolescent and adult patients (age =12 years) with nonsegmental vitiligo. These data will be presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) 30thCongress, held virtually from September 29-October 2, 2021. Building on the previously announced positive topline results from the TRuE-V program, findings from the Week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies. Results, which were consistent across both studies, showed: At Week 24, 29.9% of patients applying ruxolitinib cream achieved =75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint. More than 51% of patients applying ruxolitinib cream achieved =50% improvement from baseline in F-VASI (F-VASI50), and more than 15% of patients applying ruxolitinib cream achieved =90% improvement from baseline in F-VASI (F-VASI90), key secondary endpoints. Additional key secondary endpoints were met, including a significantly greater proportion of patients achieving =50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50) and a Vitiligo Noticeability Scale (VNS) response with application of ruxolitinib cream compared to vehicle, and a significant improvement on percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream compared to vehicle. The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions. Treatment-emergent adverse events were consistent with previous studies, with no serious treatment-related adverse events reported. As previously disclosed, based on these findings Incyte expects to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age =12 years) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) before the end of 2021. In September 2021, Opzelura™ (ruxolitinib) cream was approved by the FDA for the short-term and non-continuous treatment of mild to moderate atopic dermatitis (AD) 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.