Incyte announces positive results from phase III TRuE-V program evaluating ruxolitinib cream in patients with vitiligo.

Incyte announced positive topline results from its pivotal Phase III TRuE-V clinical trial program evaluating the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age greater than 12 years) with vitiligo. Both the TRuE-V1 and TRuE-V2 studies met the primary endpoint (p<0.0001 for both studies), demonstrating that significantly more patients treated with ruxolitinib cream 1.5% twice daily (bid) achieved a greater than 75% improvement from baseline in the facial vitiligo area scoring index (f-vasi75) compared to patients treated with a vehicle control at week 24. the studies also met key secondary endpoints including patient reported outcomes. the overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported phase ii data, and no new safety signals were observed. the long-term efficacy and safety portions of both studies will continue as planned. based on these findings, incyte plans to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age greater than 12 years) to the fda and the european medicines agency (ema) in the second half of 2021. the fda is currently reviewing a new drug application (nda) for ruxolitinib cream for the treatment of adolescents and adults (age greater than 12 years) with atopic dermatitis, a type of eczema.>