Priority review for Incyte's cream for vitiligo

15 December 2021

US biopharma Incyte (Nasdaq: INCY) has announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib cream 1.5% (Opzelura), a topical JAK inhibitor, as a potential treatment for adolescents and adults with vitiligo.

The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022.

Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes.

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