EC approves new indication for Novartis' Jakavi

The European Commission has approved Swiss pharma giant Novartis’ (NOVN: VX) 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 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. Around 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/or an enlarged spleen.

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