Incyte Biosciences Receives the MHRA’s Marketing Authorisation of Opzelura (ruxolitinib) for Non-Segmental Vitiligo with Facial Involvement
Shots:
- The MHRA has granted marketing authorization for Opzelura (15mg/g) in adults & adolescents aged ≥12yrs. with non-segmental vitiligo with facial involvement
- The decision was based on 2 P-III trials (TRuE-V1 & V2) evaluating ruxolitinib cream vs vehicle in 600+ patients aged ≥12yrs. which showed an improvement in facial & total body repigmentation over a vehicle as shown by the no. of patients reaching F-VASI-T-VASI EPs at 24wk. and in an open-label extension at 52wk.
- The results were consistent across both studies at 24wk. In both studies, 29.8% & 30.9% achieved ≥75% improvement from baseline in F-VASI75 vs 7.4% & 11.4% in vehicle. At 52wk., approx one in two of patients achieved F-VASI757 & one in three achieved ≥90% improvement from baseline in F-VASI (F-VASI90)
Ref: Businesswire | Image: Incyte
Related News:- Incyte Presents P-II Trial (SCRATCH-AD) Results of Opzelura (ruxolitinib) for the Treatment of Atopic Dermatitis at RAD 2023
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
