First myelofibrosis drug, Novartis' Jakavi, approved in Europe

Swiss drug major Novartis (NOVN: VX) received approval yesterday from the European Commission for Jakavi (INC424, ruxolitinib), a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. This is the first treatment to gain approval in Eurooe for this indication, an uncommon, life-threatening blood cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion with regard to approved the drug earlier this year (The Pharma Letter April 22). Novartis acquired rights to INC424 outside the USA from Incyte (Nasdaq: INCY) in 2009, in a deal that involved an upfront payment of $150 million to the US firm plus milestones and sales royalties of over 10% on future sales (TPL November 26, 2009).

Novartis is aiming for annual sales in the MF indication of more than $500 million. However, the drug holds potential for turnover of $1 billion if its use is widened to include other indications such as polycythemia vera (PV), a rare blood disorder that in a very small number of cases can progress to leukemia, analysts have suggested.