Polycythemia indication set to boost Jakavi sales

Data from a phase III trial of Novartis’ Jakavi has found it helps patients with the rare blood cancer, polycythemia vera.

The positive results are welcome for Novartis, which should eventually result in a new licence for the drug, which is already approved for another life-threatening blood cancer, myelofibrosis.

If approved for use in polycythemia vera, analysts expect drug to exceed the $1 billion annual sales mark, adding to Novartis’ revenues considerably.

People with the disease suffer from an overproduction of blood cells, which leads to a thickening of the blood and increased risk of blood clots. These clots can cause serious cardiovascular problems such as stroke and heart attack, resulting in increased morbidity and mortality. Patients with polycythemia vera often have enlarged spleen and additional debilitating symptoms.

Many patients treated with commonly available therapies become intolerant or resistant, which then raises the risk of the disease progressing.

The trial of Jakavi (ruxolitinib) met its primary endpoint of maintaining hematocrit control (red blood cell volume) without the need for phlebotomy (removal of blood from the body to reduce the concentration of red blood cells) and reducing spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea.

Data from the study (RESPONSE) will be presented at an upcoming medical congress and submitted to worldwide regulatory authorities this year.

Alessandro Riva, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs said: “We plan to submit these data to worldwide regulatory agencies this year, as we seek to bring ruxolitinib to patients with polycythemia vera who are no longer responding to or are intolerant of prior therapy.”

Jakavi is an inhibitor of JAK1 and JAK2, and was approved for myelofibrosis in the EU approval in August 2012. There was further good news for Novartis in November last year when a rival JAK2 inhibitor pipeline drug, Sanofi’s fedratinib, was abandoned.

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