Incyte says FDA accepts sNDA for Jafaki Incyte Corporation announced that the U.S. FDA has accepted for filing the supplemental New Drug Application for ruxolitinib as a potential treatment of patients with polycythemia vera 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 annual meeting. RESPONSE was conducted under a Special Protocol Assessment from the FDA. The Prescription Drug User Fee Act date for the sNDA for ruxolitinib is set for December 5, 2014.
Leerink biotech analysts hold an analyst/industry conference call Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including Leukemia/MDS on an Analyst/Industry conference call to be held on November 20 at 10 am.