Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation's largest independent specialty pharmacy, announced that the U.S. Food and Drug Administration has approved an expanded indication of Jakafi® (ruxolitinib). Jakafi has received expanded approval for the treatment of uncontrolled polycythemia vera, a chronic bone marrow disease, in patients who have had an inadequate response to or cannot tolerate hydroxyurea, a medication often used to reduce the number of red blood cells and platelets in the blood.
Polycythemia vera occurs when there are too many red blood cells made in the bone marrow. This surplus of blood cells can cause bleeding problems, swelling of the spleen and blood clots in the veins near the skin surface. Patients may also be at increased risk of heart attack or stroke. It is estimated that 100,000 patients in the U.S. are living with polycythemia vera, with approximately 25,000 cases considered to be uncontrolled.
Jakafi received expanded approval for use in the treatment of polycythemia vera under the FDA's priority review program and is the first drug approved for this condition. The FDA previously approved Jakafi in 2011 for the treatment of patients with intermediate or high-risk myelofibrosis, another bone marrow disorder. Jakafi is marketed by Incyte Corp.