EC approval for Incyte's Opzelura in vitiligo

The European Commission has granted a marketing authorization for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte’s (Nasdaq: INCY) JAK inhibitor is the first and only approved treatment in the European Union to offer support for repigmentation in eligible patients with non-segmental vitiligo, a chronic autoimmune disease characterized by depigmentation of skin and reduced quality of life.

"We will now work across individual countries in Europe to bring this much awaited therapy to eligible patients"Hervé Hoppenot, chief executive of the US biopharma company, said: “The approval of Opzelura by the European Commission represents a significant advancement for people living with non-segmental vitiligo with facial involvement who, until now, had no approved medical treatment to address repigmentation.