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New indication for Novartis bone marrow disorder drug cleared in Europe

Mar. 17, 2015 7:35 AM ETNovartis AG (NVS) StockINCY, NVSBy: Douglas W. House, SA News Editor
  • The European Commission approves Novartis' (NYSE:NVS) Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. Polycythemia vera is a rare blood cancer associated with the overproduction of blood cells, principally red blood cells. It is caused by a mutation in the Janus kinase 2 (JAK2) gene. It affects ~180K people in the European Union.
  • The goal of treatment is to reduce the thickness of the blood and prevent bleeding and clotting. If left untreated, the disorder can lead to blood clots, stroke and heart attack. About 25% of PV patients develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease.
  • Jakavi is an oral inhibitor of the JAK1 and JAK2 tyrosine kinases. It was previously approved for the treatment of myelofibrosis, a disorder of the bone marrow in which the marrow is replaced by scar tissue.
  • Novartis licensed ruxolitinib from Incyte (NASDAQ:INCY) for development and  commercialization ex-U.S. Incyte retains commercialization rights in the U.S.

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