Incyte Receives EMA’s CHMP Positive Opinion of Opzelura (ruxolitinib) for the Treatment of Non-Segmental Vitiligo
- The EMA’s CHMP has issued a positive opinion recommending the approval of Opzelura for non-segmental vitiligo in adults & adolescents aged 12yrs. with facial involvement
- The opinion was based on the 2 P-III trials (TRuE-V1 & TRuE-V2) evaluating ruxolitinib cream vs vehicle in 600+ patients. The results showed a significant improvement in facial & total body repigmentation as shown by the no. of patients reaching the F-VASI-T-VASI EPs @24wk. with a higher proportion of patients responding at 52wk.
- Opzelura was approved in the US for the topical treatment of nonsegmental vitiligo & is also approved for the topical short-term & non-continuous chronic treatment of mild to mod. AD in non-immunocompromised patients
Ref: Buisnesswire | Image: Incyte
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