Incyte Corp. (INCY) announced Monday positive topline results from its pivotal Phase 3 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 =12 years) with vitiligo.
Both the TRuE-V1 and TRuE-V2 studies met the primary endpoint, demonstrating 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. The overall efficacy and safety profile of ruxolitinib cream is consistent with previously reported Phase 2 data, and no new safety signals were observed.
Based on these findings, Incyte plans to submit marketing applications for ruxolitinib cream to the U.S. Food and Drug Administration (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 =12 years) with atopic dermatitis, a type of eczema.
Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes.
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