European Commission approves Opzelura for adults, adolescents with nonsegmental vitiligo

Key takeaways:

• Opzelura is the first and only approved treatment for repigmentation of nonsegmental vitiligo in the European Union.
• The approval was supported by positive results from two phase 3 trials.

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 significant improvements over vehicle in more than 600 patients aged 12 years and older.

By week 24, results showed 29.8% and 30.9% of patients in the respective studies treated with the study drug achieved greater than 75% improvement from baseline in facial and body pigmentation compared with 7.4% and 11.4% of vehicle-treated patients. Further, approximately half of Opzelura-treated patients achieved this improvement through week 52.

“The approval of Opzelura by the European Commission represents a significant advancement for people living with non- vitiligo with facial involvement who, until now, had no approved medical treatment to address repigmentation,” Hervé Hoppenot, CEO of Incyte, said in the press release. “We will now work across individual countries in Europe to bring this much awaited therapy to eligible patients seeking to treat their vitiligo.”