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Jakafi FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 27, 2021.

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 used for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.

  • Jakafi is indicated for 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.
    • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
  • Jakafi tablets are administered orally, twice daily.
  • Jakafi can cause serious adverse reactions including thrombocytopenia, anemia and neutropenia; increased risk of infection; increased risk of non-melanoma skin cancer; elevated lipids; major adverse cardiovascular events; thrombosis; and secondary malignancies.
  • Common side effects of Jakafi:
    • In myelofibrosis and polycythemia vera, the most common side effects include thrombocytopenia, anemia, bruising, dizziness, headache, and diarrhea.
    • In acute graft-versus-host disease, the most common side effects include anemia, thrombocytopenia, neutropenia, infections, and edema.
    • In chronic graft-versus-host disease, the most common side effects include anemia, thrombocytopenia, and infections.

Development timeline for Jakafi

Dec 20, 2022Ruxolitinib and methylprednisolone for treatment of patients with relapsed/refractory multiple myeloma
Sep 22, 2021Approval Incyte Announces FDA Approval of Jakafi (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.