EU approves Opzelura for non-segmental vitiligo

Opzelura is the first and only approved treatment in the European Union (EU) to offer support for repigmentation in eligible patients with non-segmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin and reduced quality of life.

The EC decision is based on data from two pivotal Phase III clinical trials (TRuE-V1 [NCT04052425] and TRuE-V2 [NCT04057573]), evaluating the efficacy and safety of Opzelura versus vehicle (non-medicated cream) in more than 600 people with non-segmental vitiligo, age 12 and older. Results from the TRuE-V program showed that treatment with Opzelura resulted in significant improvements in facial and total body repigmentation versus vehicle as shown by the number of patients reaching the facial and total body Vitiligo Area Scoring Index (F-VASI-T-VASI) endpoints at Week 24 compared to vehicle and in an open-label extension at Week 521.

Results at Week 24, which were consistent across both studies, showed that 29.8% and 30.9% of patients treated with Opzelura achieved ?75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint, compared to 7.4% and 11.4% of patients treated with vehicle in TRuE-V1 and TRuE-V2, respectively. At Week 52, approximately one in two of Opzelura-treated patients achieved F-VASI751.

Additionally, at Week 24, more than 15% of patients treated with Opzelura achieved ?90% improvement from baseline in F-VASI (F-VASI90), compared to approximately 2% of patients treated with vehicle. At Week 52, approximately one in three of Opzelura-treated patients achieved F-VASI90. There were no serious treatment-related adverse events related to ruxolitinib cream and the most common adverse reaction was application site acne.