Phase III success for Jakafi/Jakavi for Polycythemia Vera - Incyte+ Novartis

Novartis has announced that a pivotal Phase III trial (RESPONSE study) of Jakavi (ruxolitinib) compared to best available therapy has met its primary endpoint of maintaining hematocrit control (red blood cell volume) without the need for phlebotomy (a procedure to remove 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. The safety profile of ruxolitinib was generally consistent with previous studies based on initial review of the data. Data from the study (RESPONSE) will be presented at an upcoming medical congress and submitted to worldwide regulatory authorities this year.