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Back To Back FDA Approval For Incyte - This Time For Jakafi In GVHD

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  • The FDA has approved Incyte Corporation's (NASDAQ: INCY) approved Jakafi (ruxolitinib) for chronic graft-versus-host disease (GVHD).

  • The approval comes for adult and pediatric patients 12 years and older with GVHD after the failure of one or two lines of systemic therapy.

  • The approval was based on Phase 3 REACH3 study of Jakafi compared to the best available therapy (BAT) for steroid-refractory chronic GVHD after allogeneic stem cell transplantation.

  • The primary endpoint of the overall response rate at Week 24 was 49.7% for Jakafi compared to 25.6% for BAT.

  • Related: Incyte's Topical JAK Inhibitor Scores FDA Approval For Atopic Dermatitis.

  • Despite these back-to-back approvals, Incyte stock has dropped after the FDA added a Boxed Warning to flag Opzelura's safety concerns.

  • Warnings include serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, seen with JAK inhibitors for inflammatory conditions.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: INCY stock is down 7.06% at $70.71 during the market session on the last check Wednesday.

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