FDA Approves Ruxolitinib for Polycythemia Vera
US Food and Drug Administration
(HealthDay News) -- Jakafi (ruxolitinib) has been approved by the U.S. Food and Drug Administration to treat polycythemia vera.
Jakafi has been approved for polycythemia vera patients who cannot tolerate or have an inadequate response to other drugs. In clinical studies involving 222 people, Jakafi's most common side effects included anemia, thrombocytopenia, dizziness, constipation, and shingles.
The drug was first approved in 2011 to treat another bone marrow disorder, myelofibrosis.
"The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "The trial used to evaluate Jakafi confirmed clinically meaningful reductions in spleen size and the need for phlebotomies to control the disease."
Jakafi is marketed by Incyte Corp., based in Wilmington, Del.