Incyte (INCY) Announces Acceptance and Priority Review of sNDA for Ruxolitinib Cream as a Treatment for Patients with Vitiligo

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Go back to Incyte (INCY) Announces Acceptance and Priority Review of sNDA for Ruxolitinib Cream as a Treatment for Patients with Vitiligo

Incyte Announces Acceptance and Priority Review of sNDA for Ruxolitinib Cream (Opzelura™) as a Treatment for Patients with Vitiligo

December 14, 2021 4:30 PM EST

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq: INCY) today announced that the U.S. 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 (age 12 years) with vitiligo. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. The Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022.

Vitiligo is a chronic autoimmune disease that can have a profound... More