On August 5, 2014 Incyte reported 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 (Press release Incyte, AUG 5, 2014, View Source [SID:1234500688]). The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA.
The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ruxolitinib is set for December 5, 2014.
“We are pleased to have received the acceptance of our sNDA filing by the FDA, and we believe that the submission contains a robust data set,” stated Richard Levy, M.D., Executive Vice President and Chief Drug Development and Medical Officer of Incyte. “We look forward to working with the FDA to complete its review of this application”.
PV is a form of blood cancer leading to the overproduction of normal red blood cells, white blood cells and platelets. Patients with uncontrolled PV have an increased risk of cardiovascular complications such as stroke, pulmonary embolism, deep vein thrombosis and heart attack.