Incyte Gets FDA Approval for Extended-Release Version of Jakafi Treatment
By Elias Schisgall
Incyte received approval from the Food and Drug Administration for an extended-release formulation of its Jakafi treatment.
The agency approved Jakafi XR, known generically as ruxolitinib, to treat adults with intermediate- or high-risk myelofibrosis, polycythemia, or adults or children with graft-versus-host disease who have received previous lines of systemic therapy.
The approval was based on a study demonstrating that a 55mg Jakafi XR tablet once daily is bioequivalent to a 25mg Jakafi tablet in the immediate-release form taken twice daily.
"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," Chief Executive Bill Meury said. "Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice."
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
May 01, 2026 18:03 ET (22:03 GMT)
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