- The FDA has approved Jakafi (ruxolitinib), developed and marketed by Incyte Corp., for the treatment of polycythemia vera—a disease in which there are too many red blood cells being made in the bone marrow.
- Jakafi is already approved for the treatment of myelofibrosis, a disease that affects the body's ability to make blood cells.
- Jakafi is useful for patients with polycythemia vera, who have not had successful outcomes with hydroxyurea, which is frequently used to address this condition. In these patients, Jakafi can help patients avoid the problem of developing an enlarged spleen and possibly help them avoid the need for phlebotomy.
Jakafi has proven useful in addressing issues related to red blood cells. It works by inhibiting an enzyme called Janus Associated Kinase (JAK) 1 and 2, both of which are involved in immunological functioning and blood regulation.
The study leading to the approval involved 222 patients with polycythemia vera who could not tolerate hydroxyurea. Based on measurements taken between weeks 8 and 32 of the study, 21% of Jakafi-treated patients experienced a reduction in the need for phlebotomy, compared with only 1% of patients treated with hydroxyurea.