NAPSR News: FDA approves Incyte Corp’s Jakafi® (ruxolitinib) to treat uncontrolled Polycythemia Vera

WASHINGTON - Dec. 4, 2014 - PRLog -- Incyte Corporation has received approval for Jakafi® (ruxolitinib), the first and only FDA-approved oral medication for patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Polycythemia vera  (PV)  is a rare blood cancer in which the bone marrow produces too many red blood cells which can result in cardiovascular complications, such as stroke and heart attack. Other symptoms include enlarged spleen which may contribute to the blood thickening and lack of oxygen to parts of the body. Patients may experience, itching, night sweats, bone pain, fever, fatigue and weight loss.

“The approval of Jakafi represents an important advance for patients with uncontrolled PV. For the first time we are able to provide these patients a treatment that has been shown to provide effective and consistent control of their blood counts and reduce spleen volume,” said Srdan Verstovsek, M.D., Ph.D., Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

The approval was based on Phase III RESPONSE trial which indicated Jakafi was effective in demonstrating superior hematocrit control and reducing spleen volume compared to best available therapy.

“The team at Incyte is proud that a second indication has been approved for Jakafi, further confirming the strength of our science and our commitment to discovering and developing innovative treatments for patients with cancer,” said Hervé Hoppenot, Incyte’s President and Chief Executive Officer.

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