The FDA has approved Ojjaara, a drug developed by GSK plc (LSE:GSK), for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia, the pharmaceutical company announced on Monday. The approval comes following a three-month delay due to an FDA request for additional information.
Ojjaara, also known as momelotinib, was acquired by GSK last year as part of its $1.9 billion buyout of Sierra Oncology (NASDAQ:SRRA). The drug is currently the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia, addressing key symptoms of the disease such as anaemia, constitutional symptoms, and splenomegaly.
The drug's approval was broader than expected, allowing its use in intermediate- or high-risk myelofibrosis patients with anaemia, regardless of any prior therapy. This is a significant development as current therapies for myelofibrosis can exacerbate anaemia, a common symptom of blood cancer and the primary reason why people discontinue treatment.
Data from the pivotal MOMENTUM study and a subpopulation of adult patients with anaemia from the SIMPLIFY-1 phase III trial supported the FDA's approval. In the MOMENTUM trial, Ojjaara reduced the need for blood transfusions compared to danazol, a steroid used to treat anaemia. At week 24, 31% of patients treated with GSK's drug were transfusion-independent compared to 20% of a control group.
Despite its success in the U.S., Ojjaara is not approved in any other market as yet. However, GSK had previously stated that it expects the drug to generate sales as early as FY 2023.
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