Data will support planned US and EU regulatory submissions for ruxolitinib cream in vitiligo in the second half of 2021

Incyte recently unveiled positive topline results from a pivotal Phase III trial programme assessing the safety and efficacy of ruxolitinib cream, an investigational, nonsteroidal, anti-inflammatory, JAK inhibitor, topical therapy, in adolescent and adult patients (age =12 years) with vitiligo.

Both the TRuE-V1 and TRuE-V2 studies met the primary endpoint (p<0.0001 for both studies), showing that significantly more patients treated with ruxolitinib cream 1.5% twice daily (BID) achieved a =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, and no new safety signals were observed.

“These positive results – the first Phase III data to demonstrate significant improvements in facial and total body repigmentation – confirm the potential of ruxolitinib cream to be a meaningful treatment option for individuals living with and seeking treatment for their vitiligo,” said Jim Lee, Group Vice President, Inflammation & Autoimmunity, Incyte.

“We look forward to working with regulators to bring this much needed treatment option to patients. If approved, ruxolitinib cream would be the first and only medical treatment for repigmentation in vitiligo.”

Based on these findings, Incyte plans to submit marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age =12 years) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the second half of 2021.

“Vitiligo is a chronic immune-mediated skin condition that can significantly impact quality of life for those living with, and suffering from, this disease,” said David Rosmarin, Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center. “As a clinician, I am extremely encouraged by the initial findings from the TRuE-V programme and the potential to have ruxolitinib cream as a future topical treatment option for vitiligo patients, who currently have limited therapies available that effectively and safely address repigmentation.”