INCY - Incyte's Opzelura for vitiligo wins FDA approval following extended review

• The U.S. Food and Drug Administration (FDA) approved Incyte ( NASDAQ: INCY ) Opzelura cream to treat non-segmental vitiligo in patients 12 years of age and older.
• Incyte said Opzelura (ruxolitinib) is the first and only FDA-approved therapy for repigmentation in patients with vitiligo, and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the U.S.
• In March, the FDA had extended the review period of Opzelura by three months to review additional data submitted by Incyte.
• The approval was backed by data from phase 3 TRuE-V clinical program — TRuE-V1 and TRuE-V2.
• Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin.

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