The European Commission has approved Opzelura in the European Union to treat nonsegmental vitiligo with facial involvement in patients aged 12 years and older, Incyte announced in a press release.
This approval, which followed the European Medicines Agency’s recommendation in February, makes Opzelura (ruxolitinib) cream 15 mg, a selective Janus kinase 1 and 2 inhibitor, the first and only approved treatment in the European Union for this indication, according to the release.
The decision was supported by results from the phase 3 TRuE-V1 and TRuE-V2 trials in which Opzelura demonstrated