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Jakafi 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 History and FDA Approval Process for Jakafi

DateArticle
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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