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Jakafi FDA Approval History

FDA Approved: Yes (First approved November 16, 2011)
Brand name: Jakafi
Generic name: ruxolitinib
Dosage form: Tablets
Company: Incyte Corporation
Treatment for: Myelofibrosis, Polycythemia Vera, Graft-versus-host disease

Jakafi (ruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of:

  • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults.
  • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea.
  • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older.

Development Timeline for Jakafi

May 24, 2019Approval FDA Approves Jakafi (ruxolitinib) for the Treatment of Patients with Acute Graft-Versus-Host Disease
Dec  4, 2014Approval FDA Approves Jakafi (ruxolitinib) for Polycythemia Vera
Nov 16, 2011Approval FDA Approves Jakafi to Treat Myelofibrosis
Aug  3, 2011FDA Accepts NDA Filing for Ruxolitinib as a Treatment for Myelofibrosis
Jun  8, 2011Incyte Submits New Drug Application for Ruxolitinib in Myelofibrosis to the US Food and Drug Administration

Further information

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