FDA approves momelotinib for myelofibrosis patients with anemia
The US Food and Drug Administration has approved momelotinib (Ojjaara; GSK) for treating intermediate or high-risk myelofibrosis in adults with anemia, according to a press release. It is currently the only approved medication for both newly diagnosed and previously treated myelofibrosis patients with anemia, effectively addressing major symptoms of the disease including anemia, constitutional symptoms, and enlarged spleen (splenomegaly).
Momelotinib is an oral inhibitor targeting JAK1, JAK2, and ACVR1 receptors, taken once a day.
The FDA approval of momelotinib is based on data from the MOMENTUM study, which compared its effectiveness to danazol in treating myelofibrosis symptoms in anemic, JAK inhibitor-experienced patients. MOMENTUM successfully met its primary and secondary endpoints, showing significant improvement in symptoms, spleen size, and transfusion independence with momelotinib. In addition, the SIMPLIFY-1 trial assessed momelotinib against ruxolitinib in myelofibrosis patients who hadn’t previously received a JAK-inhibitor.
“The vast majority of myelofibrosis patients eventually develop anemia, causing them to discontinue treatments and require transfusions. Given this high unmet need, we are proud to add Ojjaara to our oncology portfolio and address a significant medical need in the community. We look forward to helping improve outcomes in this difficult-to-treat blood cancer,” said Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK.
Read the full press release here.