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    Home > Active Ingredient News > Drugs Articles > New indications of European Union harvest of Novartis heavyweight drug: polycythemia vera (PV)

    New indications of European Union harvest of Novartis heavyweight drug: polycythemia vera (PV)

    • Last Update: 2015-03-19
    • Source: Internet
    • Author: User
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    Source: Biovalley, March 19, 2015 news from Novartis on EU regulation recently, the oral jakavi (ruxolitinib), an oral JAK kinase inhibitor developed by Novartis, has gained new indications in the EU for real polycythemia (PV) that is resistant or intolerant to hydroxyurea , referred to as "true red") for the treatment of adult patients, the drug has also become the first PV targeted treatment drug approved by the European Union Prior to that, jakavi had been approved by the European Union for the treatment of bone fibrosis in August 2012 In the United States, the FDA approved the indications of jakafi (ruxolitinib) for bone fibrosis and polycythemia vera (PV) in November 2011 and December 2014, respectively The drug is also the first bone fibrosis and "true red" treatment drug approved by the FDA The industry had previously predicted that jakavi would easily become a heavyweight drug, with two indications each bringing in more than CHF 500 million a year for Novartis The approval of new indications for jakavi PV is based on positive data from the critical phase III response study In the study, 222 patients with polycythemia vera (PV) who were resistant or intolerant to hydroxyurea were randomized to receive ruxolitinib (10mg, twice a day) or the best treatment (single drug therapy or only observation selected by the researchers) Data show that the study reached the primary end point of maintaining controlled hematocrit (hematocrit) without bleeding (removing part of the blood from the body to reduce the concentration of red blood cells), while reducing the size of the spleen in PV patients 70% of the patients in the jakavi treatment group achieved hematocrit control or spleen volume reduction, compared with 20% in the best supportive treatment group Polycythemia vera (PV) is a chronic, incurable blood cancer, which is related to overproduction of blood cells, resulting in blood thickening and increased risk of blood clots These blood clots can cause serious cardiovascular complications, such as strokes and heart attacks, which increase morbidity and mortality Patients with polycythemia often have symptoms of splenomegaly and extra weakness Many patients become intolerant or resistant after regular treatment, which is related to the increased risk of deterioration Jakavi (ruxolitinib) is an oral Jak1 and JAK2 tyrosine kinase inhibitor Novartis authorizes ruxolitinib from Incyte to develop and commercialize ruxolitinib outside the United States In the European Union, jakavi was approved in August 2012 for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, myelofibrosis after polycythemia vera and myelofibrosis after primary thrombocytopenia Currently, jakavi has been approved by more than 50 countries around the world.
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