European Commission Approves Ruxolitinib Cream for Non-Segmental Vitiligo

Incyte recently announced the European Commission (EC) approval of ruxolitinib cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents aged 12 years and older.¹ Like in the US, ruxolitinib cream is the only EC-approved treatment for patients with non-segmental vitiligo.

The EC’s approval comes after the positive opinion received from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) earlier in the year. The EMA’s CHMP opinion was issued following the completion of 2 controlled phase 3 trials, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), which evaluated the safety and efficacy of ruxolitinib in more than 600 patients.

Data from the TRuE-V program demonstrated that treatment with ruxolitinib 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 52.

Results at week 24, which were consistent across both studies, showed that 29.8% and 30.9% of patients treated with ruxolitinib 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 ruxolitinib-treated patients achieved F-VASI75. There were no reported serious treatment-related adverse events, and the most common adverse reaction was application-site acne.

Ruxolitinib cream was approved by the US Food and Drug Administration (FDA) in July 2022, where it became the first and only FDA-approved treatment to treat non-segmental vitiligo. Ruxolitinib is also FDA-approved to treat atopic dermatitis.

In a recent Dermatology Times® Between the Lines series, “Rapid Pruritus Reduction with Ruxolitinib Cream Treatment in Patients with Atopic Dermatitis,” James Q Del Rosso, DO, Raj Chovatiya, MD, PhD, and Lisa Swanson, MD, discuss the phase 3 TRuE-AD1 and TRuE-AD2 trials evaluating the safety and efficacy of ruxolitinib cream for the treatment of atopic dermatitis.

Reference

1. Incyte announces European Commission approval of opzelura (ruxolitinib) cream for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents. Incyte. Published April 20, 2023. Accessed April 21, 2023. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-opzelurar