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

The FDA has extended the review period for Incyte Corporation's 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.