The FDA has accepted for review Incyte Corporation's (NASDAQ:INCY) supplemental marketing application seeking approval for ruxolitinib cream 1.5% (Opzelura), a topical JAK inhibitor for vitiligo.
- Under the Priority Review, the application covers adolescents and adults (over 12 years) with vitiligo, a chronic autoimmune disease characterized by skin depigmentation.
- The agency's Prescription Drug User Fee Act target action date is April 18, 2022.
- Related content: Benzinga's Full FDA Calendar.
- The submission is supported by Phase 3 TRuE-V trial data evaluating the safety and efficacy of ruxolitinib cream in more than 600 people.
- The data showed that at Week 24, 29.9% of patients applying ruxolitinib cream achieved over 75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint.
- Related: Back To Back FDA Approval For Incyte - This Time For Jakafi In GVHD.
- Price Action: INCY shares are up 1.15% at $68.59 during the premarket session on the last check Wednesday.
