GSK PLC on Friday said Ojjaara, also known as momelotinib, has been approved in the US and the ‘first and only’ treatment indicated for myelofibrosis patients with anaemia.
The London-based pharmaceutical maker explained that ‘nearly all’ myelofibrosis patients are estimated to develop anaemia over the course of the disease, with over 30% discontinuing treatment due to anaemia.
GSK said, 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, or an enlarged spleen.
‘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,’ said Nina Mojas, senior vice president of Oncology Global Product Strategy at GSK.
Myelofibrosis is a blood cancer. It can lead to severely low blood counts, including anaemia and thrombocytopaenia, a condition in which platelets are low in number.
The US Food & Drug Administration has approved the drug for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, in adults with anaemia.
The FDA approval is supported by data from the Momentum study and a subpopulation of adult patients with anaemia from the Simplify-1 phase three trial.
The Momentum study was designed to evaluate the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced patients. It met all its primary and key secondary endpoints.
Simplify-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy.
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