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FDA approves Ojjaara (momelotinib)
FDA approves Ojjaara (momelotinib).
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[{"type":"text","content":"\n\nIssued: 15 September 2023, London UK\n \nOjjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anaemia\n \n· Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy\n· Nearly all myelofibrosis patients are estimated to develop anaemia over the course of the disease, and over 30% will discontinue treatment due to anaemia[1],[2],[3] \n· Ojjaara addresses key manifestations of myelofibrosis, namely anaemia, constitutional symptoms and splenomegaly\n\n\n\nGSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia. Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. To date, it is the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that addresses the key manifestations of the disease, namely anaemia, constitutional symptoms, and splenomegaly (enlarged spleen).[4]\n \nNina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK, said: \"The vast majority of myelofibrosis patients eventually develop anaemia, 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.\"\n \nMyelofibrosis is a blood cancer affecting approximately 25,000 patients in the US.4,[5],[6] Myelofibrosis can lead to severely low blood counts, including anaemia and thrombocytopaenia; constitutional symptoms such as fatigue, night sweats, and bone pain; and splenomegaly. About 40% of patients have moderate to severe anaemia at the time of diagnosis, and nearly all patients are estimated to develop anaemia over the course of the disease.[7],[8],[9],[10] Physicians have had limited treatment options to treat myelofibrosis patients with anaemia. These patients often require transf...