Incyte announced that the Food and Drug Administration (FDA) has approved Jakafi (ruxolitinib) for the treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea. This is the first drug approved for uncontrolled PV.
The FDA approval was based on data from the Phase 3 RESPONSE trial, conducted under a Special Protocol Assessment from the FDA. Patients treated with Jakafi showed superior hematocrit control and spleen volume reductions vs. best available therapy. Also, a higher percent of patients on the ruxolitinib treatment arm achieved complete hematologic remission.
Jakafi inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation, and subsequent localization of STATs to the nucleus leading to modulation of gene expression.
Jakafi is already approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
For more information call (855) 463-3463 or visit Jakafi.com.