Novartis received the approval from the European Commission for Jakavi (ruxolitinib) for the treatment of adult patients with Polycythemia Vera (PV) who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients.
PV is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack. Approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease. This is typically defined as hematocrit levels greater than 45%, elevated white blood cell count and/or platelet count, and may be accompanied by debilitating symptoms and an enlarged spleen. Hydroxyurea’s alternative, Jakavi, is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases.
The European Commission approval applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein. Additional regulatory applications for ruxolitinib in PV are currently ongoing in countries worldwide and further regulatory filings are under review by health authorities. Ruxolitinib, which is marketed in the US by Incyte Corporation as Jakafi, received approval in December 2014 from the US Food and Drug Administration (FDA) for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea.
Dr. Claire Harrison, study investigator and Consultant Hematologist, Guy’s and St. Thomas’ NHS Foundation Trust, London, said: “The European Commission’s approval of Jakavi is encouraging news for patients. Jakavi will fill an unmet need as the first treatment shown to significantly improve hematocrit, as well as symptom control and reduce spleen size in patients with Polycythemia Vera resistant to or intolerant of hydroxyurea.“