GSK Plc: FDA Approves Ojjaara For Myelofibrosis Patients With Anaemia - Quick Facts

(RTTNews) - GSK plc (GSK, GSK.L) announced the FDA has approved Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis, in adults with 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.

The FDA approval is supported by data from the pivotal MOMENTUM study and a subpopulation of adult patients with anaemia from the SIMPLIFY-1 phase III trial. The Group noted that Momelotinib is currently not approved in any other market.

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