The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
Polycythemia vera occurs when too many red blood cells are made in the bone marrow. Patients may also experience an increase in white blood cells and platelets. An overabundance of blood cells can cause the spleen to swell, bleeding problems and blood clots in the veins near the skin surface (phlebitis). In addition, it puts patients at increased risk of stroke or heart attack.
Jakafi’s new use is intended to treat polycythemia vera patients who have an inadequate response to or cannot tolerate hydroxyurea, another medicine often prescribed to reduce the number of red blood cells and platelets in the blood. Jakafi works by inhibiting enzymes called Janus Associated Kinase (JAK) 1 and 2 that are involved in regulating blood and immunological functioning. The drug’s approval to treat polycythemia vera will help decrease the occurrence of an enlarged spleen (splenomegaly) and the need for phlebotomy, a procedure to remove excess blood from the body.
For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425677.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery