Priority Review for Incyte's ruxolitinib

FDA accepted and granted Priority Review to an sNDA from Incyte Corp. (NASDAQ:INCY) for ruxolitinib to treat polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea. The PDUFA date is Dec. 5. Ruxolitinib is also in registration in the EU for the indication.

The oral Janus kinase-1 (JAK-1) and JAK-2 inhibitor is already approved in the U.S. as Jakafi 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 as Jakavi for disease-related splenomegaly or symptoms in adults with chronic idiopathic MF, PPV-MF or PET-MF. Novartis AG (NYSE:NVS; SIX:NOVN) has exclusive, ex-U.S. rights to ruxolitinib from Incyte under a 2009 deal. ...