INCY - Incyte receives Priority Review for Opzelura to treat vitiligo

The FDA has granted Priority Review status to Incyte's (NASDAQ:INCY) sNDA for Opzelura (ruxolitinib cream) to treat vitiligo, an autoimmune disease that causes loss of skin pigmentation. The PDUFA date is April 18, 2022. The sNDA is supported by data from a phase 3 trial that showed at week 24, 29.9% of patients using ruxolitinib achieved ?75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint. Opzelura, a JAK inhibitor, was approved in September for mild to moderate atopic dermatitis in non-immunocompromised patients.

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Incyte receives Priority Review for Opzelura to treat vitiligo