Incyte's Ruxolitinib Shows Further Improvement In Facial, Total Body Re-pigmentation At 52 Weeks In Skin Disorder

Incyte Corporation INCY announced new 52-week results from its Phase 3 TRuE-V trial of ruxolitinib cream (Opzelura) in nonsegmental vitiligo. 

  • The data were presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting.
  • The 52-week results build on the previously announced positive 24-week results and include data from the 24-week double-blind and 28-week treatment extension periods of the Phase 3 TRuE-V1 and TRuE-V2 studies.
  • The Week 52 analysis showed that patients applying 1.5% ruxolitinib cream twice daily (BID) had clinically meaningful facial and total body repigmentation.
  • Related: FDA Extends Decision Date For Incyte's Ruxolitinib In Vitiligo Skin Disorder.
  • Approximately 50% of patients achieved over 75% improvement in the Vitiligo severity index compared to the improvement from baseline reported for these patients at Week 24, which was approximately 30%.
  • Nearly one-third achieved over 90% improvement in the Vitiligo severity index. 
  • The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data. There were no clinically significant application site reactions or treatment-related severe adverse events related to ruxolitinib cream.
  • Price Action: INCY shares are up 0.70% at $79.01 during the market session on the last check Monday.
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