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FDA approves Jakafi for polycythemia vera

December 5, 2014 2:09 AM UTC

FDA approved an sNDA under Priority Review for Jakafi ruxolitinib from Incyte Corp. (NASDAQ:INCY) to treat patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Incyte said Jakafi is the first treatment to be approved in the U.S. for the indication. The drug is under review in the EU for PV.

The oral Janus kinase-1 (JAK-1) and JAK-2 inhibitor is already approved in the U.S. for intermediate or high-risk myelofibrosis (MF), including primary MF and post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). The drug is approved in the EU to treat disease-related splenomegaly or symptoms in adults with chronic idiopathic MF, PPV-MF or PET-MF. ...