The approval was based on the P-III (TRuE-V1 & V2) trial evaluating the safety and efficacy of Opzelura vs vehicle in 600+ patients aged ≥12yrs. with nonsegmental vitiligo
The results showed a significant improvement in VASI scores representing improvements in facial and total body repigmentation @24 & 52wk. The results were consistent across both studies @24wk., ~30% vs 8% and 13% in (TRuE-V1 & V2) trial & ≥15% vs 2% of patients achieved ≥75% & ≥90% improvement from baseline in F-VASI75 & F-VASI90 @24wk.; ~50% & ~30% @52wk.
The company also launched a patient support program i.e., IncyteCARES that provide access to eligible patients to use Opzelura & also offers financial assistance, ongoing education, and resources
Ref: Bussinesswire | Image: Incyte
