Singapore gives nod to GSK's Omjjara (momelotinib) as first treatment indicated for myelofibrosis patients with anaemia

March 24, 2025 | Monday | News

Approval is for use in myelofibrosis patients with moderate to severe anaemia who are JAK-naive or previously treated with ruxolitinib

GSK Singapore has announced that Omjjara (momelotinib) has been locally approved for treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naive or have been treated with ruxolitinib.

Omjjara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.

Myelofibrosis can lead to low blood counts, including anaemia and thrombocytopaenia; constitutional symptoms such as fatigue, night sweats, and bone pain; and splenomegaly. About 40% of patients globally 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. These patients may become transfusion-dependent and more than 30% will discontinue treatment due to anaemia. Patients who are transfusion-dependent are often associated with a poor quality of life and have a poor prognosis with shortened survival.

Earlier treatment options for managing myelofibrosis-related anaemia have demonstrated limited efficacy and durability of response; and while JAK inhibitors are often used, they can sometimes exacerbate anaemia. This highlights an unmet need for effective treatments for myelofibrosis patients with anaemia.

 

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