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Incyte Corporation (INCY) Release: FDA Accepts Supplemental New Drug Application For Jakafi® (Ruxolitinib) And Priority Review Granted



8/5/2014 10:03:59 AM

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WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for ruxolitinib as a potential treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA.

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