Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.). The approval came a day before the Sept. 16 PDUFA date, which had been extended by three months in June to allow the agency to review recently submitted data. A rare blood cancer characterized by dysregulated JAK-signal transducer and resulting in splenomegaly and progressive anemia, myelofibrosis affects roughly 25,000 people in the U.S.