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
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