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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.
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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