FDA Extends Decision Date For Incyte's Ruxolitinib In Vitiligo Skin Disorder

• The FDA has extended the review period for Incyte Corporation's (NASDAQ:INCY) supplemental application for ruxolitinib cream (Opzelura) for vitiligo. 
• The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18 from April 18.
• The FDA extended the PDUFA action date to review additional data from the ongoing Phase 3 studies submitted by Incyte in response to the FDA's information request. 
• The pivotal Phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2) is evaluating the safety and efficacy of ruxolitinib cream versus vehicle in more than 600 adolescent and adult patients (age 12 and older) with non-segmental vitiligo.
• In October 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. 
• Price Action: INCY shares are down 0.70% at $73.43 during the market session on the last check Monday.