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Incyte's Ruxolitinib Cream Aces Late-Stage Vitiligo Trials, Teeing Up Regulatory Submissions

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Incyte's Ruxolitinib Cream Aces Late-Stage Vitiligo Trials, Teeing Up Regulatory Submissions
  • Incyte Corporation (NASDAQ: INCY) has announced positive topline results from its pivotal Phase 3 TRuE-V trial program evaluating ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo, a skin condition defined by the loss of pigment cells.
  • Phase 3 trials of ruxolitinib cream have met their primary endpoints. The success of the topical JAK inhibitor tees Incyte up to seek approval in the U.S. and Europe in the second half of the year.
  • Incyte said ruxolitinib beat placebo in terms of the proportion of patients whose facial vitiligo improved by 75% or more at Week 24.
  • Details of how many patients met the F-VASI75 vitiligo score criteria remain under wraps, but Incyte said the overall efficacy and safety profile is consistent with its phase 2 results.
  • In the earlier trial, 21% of patients who used the phase 3 dose—ruxolitinib cream 1.5% twice daily, experienced a 75% improvement by Week 24.
  • The F-VASI75 rate rose to 66% by Week 104, although the figure comes from a smaller cohort as 41% of people were lost to follow-up. F-VASI75 at Week 52 was 37%.
  • No new safety signals were observed. Incyte will prepare to file for approval while continuing the long-term efficacy and safety portions of the studies. Filings for approval for use in adolescents and adults in the U.S. and EU are planned for the second half of 2021.
  • Price Action: INCY shares are up 0.41% at $82.96 during the market session on the last check Monday.
 

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Posted-In: Briefs VitiligoBiotech News Health Care FDA General

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