Shots: 

• The approval is based on JAKARTA and JAKARTA2 clinical trials. JAKARTA study involves assessing Inrebic (500mg) vs PBO for at least 6 cycles in 289 patients in patients with intermediate-2 or high-risk MF- post-polycythemia vera MF or post-essential thrombocythemia MF with splenomegaly and platelet count ≥50 x 109/L
• The P-II JAKARTA 2 study involves assessing of Inrebic (400mg- qd) in 97 patients prior exposed to ruxolitinib with a diagnosis of intermediate-1 with symptoms- intermediate-2 or high-risk MF- post-polycythemia vera MF or post-essential thrombocythemia MF with splenomegaly and platelet count ≥50 x 109/L.1
• The 1EPs of the studies is ≥35% reduction in the volume of spleen size at the end of Cycle 6. Inrebic is a JAK inhibitor and is the first new treatment for patients with myelofibrosis in nearly a decade

­ Ref: PRNewswire | Image: BMS