FDA nod for Incyte's Opzelura as vitiligo treatment

The US Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, the drug’s developer, Incyte (Nasdaq: INCY), announced late Monday, when the firms share closed up 3.2% at $81.36.

Opzelura is the first and only FDA-approved treatment for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the USA. Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin.

The FDA’s decision to clear the new indication for the topical JAK1/JAK2 inhibitor came after a priority review that was delayed by a request for additional data by the regulator, holding back a decision by three months.