Incyte (INCY) announced that the U.S. Food and Drug Administration has approved Jakafi XR extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis; adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease or chronic GVHD after failure of one or two lines of systemic therapy. “The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD,” said Bill Meury, Chief Executive Officer, Incyte. “Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice.”
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