Incyte announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Jakafi (ruxolitinib) for the treatment of polycythemia vera in patients who have inadequate response to or intolerant of hydroxyurea.
The sNDA includes results from the RESPONSE Phase 3 trial, a global, randomized, open-label trial that included 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib (10mg twice daily) or best available therapy. The primary endpoint was met.
Jakafi is the first JAK1/JAK2 inhibitor approved for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post–polycythemia vera myelofibrosis, and post–essential thrombocythemia myelofibrosis.
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