On July 18, 2022, local time in the United States, the FDA approved Opzelura (rucotinib, rusotinib) 1.5% cream for topical treatment of non-segmental vitiligo in adults and pediatric patients ≥12 years old. This is the first topical JAK inhibitor cream to be used to treat people aged 12 years and older. The approval of
FDA is based on data from the critical Phase 3 TRuEV clinical trial program (TRuEV1 and TruEV2), which evaluates the safety and effectiveness of Opzelura in more than 600 patients with non-segmental vitiligo aged 12 and older.
In the study, treatment with Opzelura resulted in a significant improvement in VASI score, which represents an improvement in facial and systemic pigmentation at week 24 (preliminary analysis) compared with vehicle (non-drug cream) and an open-label expansion was performed at week 52. The results of
Week 24 were consistent with the two studies showing that about 30% of patients treated with Opzelura had an improvement of ≥75% compared with baseline in the primary endpoint facial vitiligo area score index (FVASI75), which was the primary endpoint, while about 8% and 13% of patients treated with TRuE-V1 and TRuE-V2 controls, respectively. At week 52, approximately 50% of patients treated with opzelura achieved F-VASI75.
Additionally, at week 24, more than 15% of patients treated with opzelura achieved a baseline improvement of ≥90% in FVASI (FVASI90), compared with approximately 2% in patients treated with vehicle. At week 52, the percentage of patients treated with Opzelura reached FVASI90 doubled to about 30%.
FDA finally approved the indication of vitiligo in Rusotinib cream, and vitiligo patients have ushered in the first drug in human history!
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